7-3 BLR 9490 Cartridge Packaging Validation

B+ L Title: Reusable Injector Cartridge Ship Test Document Number: BLR9490 I Revision: A I Page 1 of 63

AUSCH LOMB Global Packaging Engineering

Rochester, NV

Reusable Injector Cartridge Ship Test Report

BLR9490

Prep a red By: __ $--+--~+--____."4z ..... .t"" .u.N:w..Jo;;;?;oj,dl-r __ Troy Painton

Sr. Packaging Engineer

Approval Signatures I Dates Project Manager: Sushant Muchhala .5~ ~ A.Jc4AcJ._...j--. Date: Global Packaging Manager: Brian Buxton ( ill i:. ~ Date: G /t 3/13

\....!;../",

D&R Engineering: Will Sea S~t:' A.+!~ Date: Global Regulatory Affairs: Jason Smith S-e-c: J. -'-J.. . A. ..J,-......._ Date:

EMO: Randy Woods ~

a L Ill!!:. Reuuble Injector Cartridge Ship Test Document Number: BLR9490 Revision: A

AUSCH OM Global Packaging Engineering

Rochester, NY


BLR9490

Prepared By: -~----~'--~.,__-J.l2~atJ""'A1~g..""a'.-r-Troy Painton


Approval Signatures I D.. { r;).D 1 Global Packaging Manager: Brian Buxton Date:

D&R Engineering: Will Seo

Date: ~/{3/13 EMO: Randy Woods Date:

Global Quality: Sanaz Sotodeh Date: o6 -JIN1~~13 Supplier Quality: Joe Melnick Date: /~rt..2~/ g Medicel: Tobias Maier Date:

CONFIDENTIAL 2

..

' ; . l ; l. : .... !!!!!:. Reusable Injector Cartridge Ship Test ~ '~ .. .. ! ---

. t. _ ... J

Document Number: BLR9490 I Revision: A I Page 1 of 63

Global Packaging Engineering Rochester, NY


BLR9490

Prepared By: --~-t--~~-____.:..=z ....... ~J ..... M .... z.~r~~.-e __ Troy Painton


Project Manager: Sushant Muchhala Date:

Global Packaging Manager: Brian Buxton Date:

D&R Engineering: Will Seo Date:

Global Regulatory Affairs: Jason Smith Date:

EMO: Randy Date:

Global Quality: Sanaz Date:

Supplier Quality: Joe Melnick Date:

Medicel: Tobias Maier Date:

-)J

CONFIDENTIAL 3

B Title: Reusable Injector Cartridge Ship Test Document Number: BLA9490 Revision: A Page1 of 63

BAUSC 0 Global Packaging Engineering

Rochester, NV


BLR9490

Prepared By: __ &-+--~-+--___..,.z...,...""'""""'-e.""d'-r __ Troy Polnton


I -- -.-,;.: -- -

~-~pr-oval Signatures I Dates .: . .I .. : ' I -- -

-





EMO: Randy Woods Date:

Global Quality: Sanaz Sotodeh Date:

Supplier Quality: Joe Melnick /} Date: Medicel: Tobias Maler 6 )iJr Date: !\~~"' 2.dt

"" ...... .....

CONFIDENTIAL 4


Table of Contents

1 EXECUTIVE SUMMARY 4 2 INTRODUCTION 4 3 PURPOSE 4 4 SCOPE 4 5 DEFINITIONS, ACRONYMS, AND ABBREVIATIONS 4 6 REFERENCES 5 7 RESPONSIBILITIES 5 8 PRE-REQUISITES AND GENERAL REQUIREMENTS 5 9 SAMPLING PLAN AND RATIONALE 6 10 TEST SAMPLE PREPARATION 6 11 TEST PROCEDURE 6 12 POST SHIP TEST INSPECTION 9 13 PRODUCTION DISPOSITION 11 14 DEVIATIONS TO THE PROTOCOL 11 15 SUMMARY 11 16 ATTACHMENTS 11

CONFIDENTIAL 5


REVISION HISTORY

Revision No. Revision History Author

Original Document T. Painton

Date

6/12/2013

CONFIDENTIAL 6

B L Title: Reusable Injector Cartridge Ship Test Document Number: BLR9490 Revision: A Page 4 of 63

1.0 EXECUTIVE SUMMARY

This report documents the proposed packaging configuration for the AX-Xl reusable injector cartridges for Project ROSOl ability to withstand the anticipated distribution hazards.

One deviation occurred during functional lens delivery. Functional lens delivery was re-executed, according to DFU procedures, and acceptance criteria were met. See Deviation Form in Attachment 5 for additional details.

This transportation test documents evidence the reusable injector cartridge packaging configuration protects the product when exposed to the hazards of normal handling, storage and distribution per ISTA 3A standard and the product delivers lenses as intended. This transportation test provides documented evidence of compliance with applicable IS0-11607-1:2009 requirements. Therefore, the reusable injector cartridge packaging configuration has met all acceptance criteria.

2.0 INTRODUCTION

This report documents the proposed packaging configuration for the AX-Xl reusable injector cartridges for Project ROSOl ability to withstand the anticipated distribution hazards.

3.0 PURPOSE

This transportation test provides documented evidence the reusable injector cartridge packaging configuration protects the product when exposed to the hazards of normal handling, storage and distribution per ISTA 3A standard.

This transportation test provides documented evidence of compliance with applicable IS0-11607-1:2009 requirements.

4.0 SCOPE

This verification is limited to the AX-Xl reusable injector cartridges being developed under B&L Project ROSOl. Cartridges are manufactured and packaged at Medicel.

5.0 DEFINITIONS, ACRONYMS, AND ABBREVIATIONS

Name Description AVC Bausch & Lomb Aliso Viejo, CA B&L Bausch and Lomb oc Celsius (in degrees)

DDL Distribution Dynamic Labs ISTA International Safe Transit Association N/A Not Applicable

No. or# Number P/N Part Number PC Procedural Choice

CONFIDENTIAL 7


Name Description RH Relative Humidity

SOP Standard Operational Procedure % Percent

6.0 REFERENCES

Document #/Rev Document Title

ASTM F2096-11 Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) Viscoject 1.8 Cartridge Medicel control card for Building Axiom IOL Delivery System Xl

Set instructions, Rev. 00 Cartridge Viscoject 2.2 Cartridge Medicel control card for Building Axiom IOL Delivery System Xl

Set instructions, Rev. 00 Cartridge

ISTA 3A-2008 Packaged-Products for Parcel Delivery System Shipment 70kg (150lb) or less FP-3244, Rev F enVista MX60 IOL

ISO 11979-5:2006 Ophthalmic implants-- Intraocular lenses

7.0 RESPONSIBILITIES

Group Responsibilities

B&L Global Packaging Wrote the protocol and final summary report Arranged for testing at the ship test facility

Medicel Test sample builds B&L AVC Functional Lens Delivery

DOL -Testing Subjected test samples to the conditioning and test parameters Laboratory Returned test samples to B&L Aliso Viejo, CA

8.0 PRE-REQUISITES AND GENERAL REQUIREMENTS

Training- Current Good Manufacturing Practices for Medical devices were followed throughout the execution of the protocol. Operators were trained and training is documented in Attachment 2.

Process Equipment- No new computer systems or processing equipment were implemented that would require validation before the procedures executed. Measurement equipment was appropriate for the attributes being measured and capable of providing meaningful and valid results.

Process Materials/Components- Materials and packaging components for this study were inspected, approved and released for use prior to any testing.

CONFIDENTIAL 8


9.0 SAMPLING PLAN AND RATIONALE

Sample size of six (6) cartons, sixty (60) cartridges in total, were used to for this testing. Hot and cold environmental conditioning was conducted on three (3) carton test samples at each condition. Functional lens delivery testing was included as part of the acceptance criteria. Ten lenses were delivered for each environmental condition parameter to satisfy the minimum requirements of ISO 11979:2006. enVista MX60 lenses with various diopters were used for functional lenses delivery. AX-R1 Handpieces from BLP9489 were used for lens delivery. Handpiece serial numbers were recorded in the lens delivery datasheets. Lenses delivery was captured in BLP9489 datasheets and is included in Attachment 6.

10.0 TEST SAMPLE PREPARATION

The following procedures were followed for protocol execution:

10.1 Built and packaged sixty (60) cartridges per Medicel control card Viscoject 1.8 and 2.2 Cartridge Set instructions for Axiom IOL Delivery System X1 Cartridge

10.2 Placed packaged cartridge samples into over shipper. Labeled outside of shipper with BLP9490.

10.3 Shipped test samples to test facility at the address below via expedited air I truck shipment:

DDL, Inc. 10200 Valley View Road, Suite #101 Eden Prairie, MN 55344

11.0 TEST PROCEDURE

The following procedures were followed for protocol execution:

11.1 Upon receipt of test sample at the test facility, the test samples were removed from its over-packaging and subjected to each of the following environmental conditions for no less than 72 hours.

#of Cartons Test Condition Temperature I RH Duration 3 Cold -10C 5 I Uncontrolled Relative 72 hours Humidity

+50C 5 I 85% 5 Relative Humidity 48 hours 3 Hot Then

+60C 5 I 85% 5 Relative Humidity 24 hours

The total time exposed is included in the report from test laboratory. Report in Attachment 3.

CONFIDENTIAL 9


11.2 Identification of test sample faces, corners, and edges:

11.3 Drop Sequence: 9 drops were performed per ISTA 3A as indicated in the following:

11.4 Random Vibration: Random vibration will be completed per ISTA 3A as indicated in the following:

NOTE: No top load weight is required based on the top load calculations are less than 2Sibs.

CONFIDENTIAL 10

B+ L Document Number: BLR9490

Frequency PSD Level, (It;:) gl/Hz 1 0 0.0007 30 002 50 0.02 7.0 0.001 12.0 0.001 150 0004 24.0 0.004 280 0001 360 0001 420 0003 750 0.003

2000 0.000004

Title: Reusable Injector Cartridge Ship Test

I Revision: A

c Cl) II.

0.1

001

0.001

0 0001

0.00001

0 000001

1ST

/

A3 A.

I

/

I I

I Page 8 of 63

0 ver-the-Road Trailer s l)ectrum

' --

--

f I \ } I -

--

-- \ = =

-

_l \ -

...............

I I Ill 10 100

Frequency, Hz.

11.5 Random Vibration: Random vibration was completed per ISTA 3A as indicated in the following: ISTA 3A - Pick-up and Delivery Vehicle Spectrum

Frt qJt ncy PSDLevlll, (Hz) g2niz -+- -- --+----1.0 0.001 . 0 0.035 .0 0.035 i .O . 0 03 H.O 0.0003 1;.0 0.001 2t.O 0.001 \: -- =J -\_- -1---- _,, 23.0 0.0001 5).0 0.0001 \ \ n .o 0.002 1(0.0 0.002 2~0.0 0.00005

-t--- -+----I I

0~0011 ~--~~~--~W4----L--L-L~~~--~-1 10 100

Frequency, Hz.

11.6 Drop Sequence: 8 drops were performed per ISTA 3A as indicated in the following:

CONFIDENTIAL 11

B L Title: Reusable .Injector Cartridge Ship Test Document Number: BLR9490 Revision: A Page 9 of 63

11.7 Upon completion of the ISTA 3A procedure, one(1) carton from each environmental conditioning group was overnight delivered to B&L:

Attention: Sushant Muchhala Bausch+ Lomb 30 Enterprise, Suite 450 Aliso Viejo, CA 92656

Remaining 2 cartons from each environmental conditioning group were bubble leak tested per ASTM F2096-11.

12.0 POST SHIP TEST INSPECTION

12.1 The following evaluations were executed post ship testing at B&L Aliso Viejo:

Product Inspection: Evaluate 10 cartridges (1 carton) from each temperature condition. Visually inspect carton label legibility, carton, DFU, and sealed cartridge packaging for damage under normal office lighting conditions.

Acceptance Criteria

Carton label must be legible. Carton, DFU, and handpiece must not have any excessive damage when viewed under normal office lighting conditions.

Results

Visually inspected 10 cartridges, from each temperature condition, for carton label legibility. Visually inspected 10 cartridges, from each temperature condition, carton, DFU, and handpiece for damage under normal office lighting conditions. All acceptance criteria were met. Documented the results in Attachment 4 datasheets.

CONFIDENTIAL 12

B+ L Title: Reusable Injector Cartridge Ship Test Document Number: BLR9490 I Revision: A I Page 1 0 of 63

Functional Lens Delivery: Following product inspection deliver 10 lenses, one per cartridge, from each temperature condition. Verify dimensional acceptance per the following:

Finished Product Specification

FP-3244

Drawing Number

BL000024661, Rev. A BL000024653, Rev. A

Results were documented in Attachment 5.

Acceptance Criteria

Spherical Power Range

O.OD to +4.0D +10.0D to +34.0D

All lenses must meet dimensional acceptance per the following:

Results


FP-3244

Drawing Number

BL000024661, Rev A BL000024653, Rev A


O.OD to +4.0D +10.0D to +34.0D

Delivered 10 lenses, two per handpiece, from each temperature condition . Verified dimensional acceptance per the following:


FP-3244

Drawing Number

BL000024661, Rev A BL000024653, Rev A


O.OD to +4.0D +10.0D to +34.0D

All acceptance criteria were met. Documented results in Attachment 5 datasheet.

12.2 The following evaluations will be executed post ship testing at DDL:

Bubble Leak: Evaluate 20 cartridge trays (2 cartons) from each temperature condition. Perform bubble leak testing per ASTM F2096-11. Verify no leaks occur. Document the results in Attachment 6 datasheets.

Acceptance Criteria

Verify no leaks occur

CONFIDENTIAL 13


Results

Perform bubble leak testing per ASTM F2096-11. No leaks occur. All acceptance criteria were met. Documented results in Attachment 6 datasheets.

13.0 PRODUCT DISPOSITION

The protocol manager will disposition all package samples produced and used for the purposes of this study within three months after the summary report is completed and approved.

Product utilized for this study is for experimental purposes only and not for commercial use.

14.0 DEVIATIONS TO THE PROTOCOL

One deviation occurred during functional lens delivery. During the functional lens delivery section of the 'Post Ship Test Inspection', plunger tip override was observed on lens sample #35 (serial number: 3217315002). The plunger tip rode on top of the lens optic approximately 0.5 to 1.0 mm but was able to advance and exit the lens from the inserter with the plunger tip over the lens optic. However per the DFU, the user is to ensure that the plunger remains behind the lens until the lens fully exits the inserter tip.

Due to lens #35 (serial number: 3217315002) not remaining in front of the plunger tip during lens delivery, the sample was not used as part ofthe functional delivery testing data and was replaced with lens serial number 3350608019 and retested. The operator ensured that the plunger tip remained behind the lens during the delivery and the post-cosmetic delivery acceptance criteria were met.

15.0 SUMMARY

This transportation test documents evidence the reusable injector cartridge packaging configuration protects the product when exposed to the hazards of normal handling, storage and distribution per ISTA 3A standard and the product delivers lenses as intended. This transportation test provides documented evidence of compliance with applicable IS0-11607-1:2009 requirements. Therefore, the reusable injector cartridge packaging configuration has met all acceptance criteria.

16.0 ATTACHMENTS

Attachment 1-Ship Test Plan Attachment 2- Training Record Attachment 3 - DDL Report Attachment 4- Visual Inspection Attachment 5- Lens Delivery Attachment 6- Bubble Leak

CONFIDENTIAL 14


Attachment 1- Ship Test Plan

Sample Preparation

Medicel built test samples

! Ship Testing

Environmental conditioning, vibration, and drop testing were be conducted at DDL packaging test lab

+ Bubble Leak Testing

Bubble leak tested at DDL packaging test lab

! Test Sample Inspection

Visual inspection and functional lens delivery at Bausch & Lomb Aliso Viejo, CA

~ Generate Report

Global Packaging generated a report

CONFIDENTIAL 15


Attachment 2- Training Record

CONFIDENTIAL 16

B+ Title: Reusable Injector Cartridge Ship Test Document Number: BLP9490 Revision: A Page 11 of 15

Attachment 1 -Training Record

BAUSCH LO B Training Record

Reusable Injector Cartridge Ship Test BLP9490

t----------+- -- - - ----11-------4--------f-------4

Training Verification:

Date:

B+L 18.1.2-GFORM-14

11 of 15 Revision: A

CONFIDENTIAL 17

B L Title: Reusable Injector Cartridge Ship Test Document Number: BLP9490 I Revision: A I Page 11 of 15

Attachment 1 - Training Record

BAUSCH

1

I:S.U.I~ "Th'~

/AJIJ_( S'~o

Training Verification:

Date:

B+L 18.1.2-GFORM-14

..,

Training Record

wm Reusable Injector Cartridge Ship Test

l::riir. . . . L!U1: ~ ~~I t .

L ~;,-fA /=>736;:;.-. ~ ( 1 /

!O:JuAJzo, 3

LOM lrTil

BLP9490

.~, , ~

SdfL

. .

A

:~

/D .:ru~- '2.c..r3

11 of 15 Revision : A

CONFIDENTIAL 18


Attachment 3- DDL Report

CONFIDENTIAL 19

Transportation Simulation Testing for the

Bausch & Lomb Reusable Injector Handpiece Ship Test & Reusable Injector

Cartridge

Report Number: R1304158-01-00 Bausch & Lomb Protocol Numbers: BLP9489 Rev. A and BLP9490, Rev. A

PO Number: Credit Card Payment

DOL, "W.o:r

11June2013

Client: Bausch & Lomb Contact: Troy Painton

1400 N Goodman Street Rochester, NY 14609

Test Performed by:

DDL Tested and proven.

DOL, ? ...... 17371 Mt. Wynne Circle, Suite A

Fountain Valley, CA 92708 tel : 714.979.1712 1800.229.4235

fax: 714.979.1721

10200 Valley View Road, Suite 101 Eden Prairie, MN 55344

tel: 952.941.9226 1800.229.4235 fax: 952.941.9318

www.testedandproven.com

CONFIDENTIAL 20

TABLE OF CONTENTS

Revision Record .................................................................................................. 2

Introduction ......................................................................................................... 2 Objective ... ... ...... ....... .................................... .... .................................. .. ....... ... ..... .... ... ..... ... ... ... . 2 Scope ....... ...... ...... .. ............. .. ... ... .... .... ........ .. .. ....... .. ....... ... ..... ....... ... .... .... .. ........ ..... ...... ... ... ...... 2

Summary of Tested Specimens ......................................................................... 2

Packaging System .............................................................................................. 3 Protective Package ............................................. ........................................... .... ........................ 3

Shipping Unit ..... ............ ........... ....... .................................... ........... ...... ..... .. .... .................... 3 Sterile Barrier System .......... .......... .......... ... ..... ... ... .... .................... .... ... ..... .... .............. .............. 3

Product ................................................................................................................ 4

Results Summary ................................................................................................ 4 Acceptance Criteria .. ..... .... ..... ..... .. ... .... ........ ... .. ..... ... ... .. .. ....... ... ... .. .......... .. .. .... .. ... ... .... .... ... ... .. 4 Environmental Conditioning ................. ....... .. .. .. ........ .. ..... ...... ......... .. .. .... .. ..... ..... ...... ...... ... ..... ... 4 Distribution Simulation Testing ........... ........................... .. ...... ...... ....... .................... ........ ... ..... ... 4 Package Integrity Testing ........................ ........ .... ... ... .. .. ... ................... ................. .... ... .... .. .... .. .. 5

Bubble Leak Testing ......... .. ............ ........... ........ ...... .. .... .. ........... .................. .. .. ....... .. ...... .. . 5

Related Documents ............................................................................................. S

Logistics .............................................................................................................. 6

Equipment/Materials ........................................................................................... 6

Test Procedure .................................................................................................... 7 Environmental Conditioning .................. ....... .... .. ...... ...... ... .................. ...... ........ ....... ... ...... ......... 7 Distribution Simulation ........................... .. .... .... ... ... ... ... ... .......... ........ ....... ... ... .. .. ... .. ... .. .. .. .......... 7

Drop Test. .... .......... ....................... .......................... ................. .. ............ ......... .. ................... 8 Vibration under Dynamic Load (Over-The-Road Trailer Simulation) ....... ........ ............... .... 9 Random Vibration (Pick-Up and Delivery Vehicle Simulation) ............... ........ .................. 10 Drop Test. .............. ........ .. .......................... ............................................ .. ....... ... .... .... .. ...... 11

Package Integrity Testing .............. ...... ........... ..... .... .. ........ ....... ...... ............ ....... ..... ....... .... ...... 12 Bubble Leak Test ........... ..... ...... ...... .. ..... .............. ...... .... .... .... ... ........ ......... ... ........ ............ 12

Disclaimer of Warranties .................................................................................. 13

Statement of Conformity .................................................................................. 14

Appendix A: Environmental Conditioning Data ............................................. 15

Appendix 8: Distribution Simulation Data ...................................................... 16

Appendix C: Bubble Leak Data ........................................................................ 17

I Report No. I R1304158-01-00 Customer: I Bausch & Lomb Page 1 of 17 DOL Inc 10200 Valley View Road Suite 101 Eden Prame MN 55344 Tel 952-941-9226 Fax 952941-9318

DOL West 17371 Mount Wynne C1rcle Suite A Founta1n Valley CA 92708 Tel 714-979-1712 Fax 714979-1721

CONFIDENTIAL 21

REVISION RECORD

Table 1: Revision Record

INTRODUCTION

Objective The objective of this project was to perform testing on the Reusable Injector Handpiece Ship Test & Reusable Injector Cartridge package design(s) for Bausch & Lomb as stated in DOL, Inc. quote number 01304158-04 and Bausch & Lomb protocol numbers BLP9489 Rev A and BLP9490 Rev. A

Scope This report documents environmental conditioning, distribution simulation, and bubble leak testing on DOL, Inc. specimen number(s) 235488-235503. Testing was done under controlled laboratory conditions with equipment qualified to perform these tests.

SUMMARY OF TESTED SPECIMENS

Specimen Number(s) Bausch & Lomb Protocol # Quantity Tested 235488 - 235497 BLP9489 Rev. A 10 Shippers 235498 - 235503 BLP9490 Rev. A 6 Shippers

Table 2: Break Down of Specimens per Bausch & Lomb Protocol

Specimen Number(s) Testing Performed Quantity Tested 235493 - 235497 & Hot Conditioning 8 Shippers 235501 - 235503 235488 - 235492 - Cold Condtioning 8 Shippers 235498 - 235500

235488 - 235503 Distribution Simulation - Post Conditioning 16 Shippers 235498 - 235499 & Bubble Leak- Post Conditioning I Distribution 40 Trays 235501 -235502 Simulation

Table 3: Summary of Tested Specimens

I Report No. I R130415B-01-00 I Customer: I Bausch & Lomb Page 2 of 17 DOL Inc 10200 Valley View Road SUite 101 Eden Pra1ne MN 55344 Tel 952-941-9226 Fax 952 941-9318

DOL West 17371 Mount Wynne Circle Su1te A Fountam Valley CA 92708 Tel 714-979-1712 Fax 714979-1721

CONFIDENTIAL 22

PACKAGING SYSTEM

Protective Package Shipping Unit The shipping unit(s) consisted of corrugated container(s) which contained 10 sterile barrier system(s) . The approximate weight(s) and outside dimensions were as follows:

Specimen Number(s) Weight (lbs.) Length (in.) Width (in.) Height (in.) 235488 - 235497 0.20 7.00 3.00 1.50 235498 - 235503 0.15 4.00 3.50 2.25

Table 4: Shipping Unit Description

Figure 1: One of the Shipping Units as Tested

Sterile Barrier System The sterile barrier system consisted of a single barrier tray with Tyvek Lid .

Figure 2: The Sterile Barrier System

I Report No. I R1304158-01-00 I Customer: I Bausch & Lomb Page 3 of 17 DOL Inc 10200 Valley View Road Su1te 101 Eden Prame MN 55344 Tel: 952-941-9226 Fax 952 941-9318

DDLWest 17371 MountWynneC1rcle Su1teA FountamValley CA92708 Tel 714-979-1712 Fax 714-9791721

CONFIDENTIAL 23

PRODUCT

Reusable Injector Handpiece & Reusable Injector Cartridge

RESULTS SUMMARY

Acceptance Criteria The acceptance criteria have been outlined in Bausch & Lomb protocol numbers BLP9489 Rev A and BLP9490 Rev. A. Bausch & Lomb personnel are responsible for determining the acceptance criteria for the package and product.

Environmental Conditioning Environmental conditioning was performed on 16 shipper(s) per Bausch & Lomb protocol numbers BLP9489 Rev A and BLP9490 Rev. A Sec. 1 0.1. The following table describes the conditions and durations for environmental conditioning:

Test Interval Specimen Number(s) Condition Duration (hrs.) 235488 - 235492 &

-10C (+/-SC)@ Uncontrolled RH 72 235498 - 235500

Initial Test sooc (+/-SC)@

48 235493 - 235497 & 8S% RH (+/- S% RH) 235501 - 235503 60C (+/-SC) @ 24

8S% RH (+/- S% RH) TableS: Environmental Conditioning Cycle

The data for the environmental conditioning is located in Appendix A of this test report.

Distribution Simulation Testing Distribution simulation testing was performed on 16 shipper(s) per Bausch & Lomb protocol numbers BLP9489 Rev A and BLP9490 Rev. A Sec. 10.3 - 1 0.6. The distribution simulation cycle is outlined in the table below:

Test Interval Specimen Number(s) Condition Post Environmental Conditioning 235488 - 235503 ISTA 3A - Shock and Vibration

Table 6: Distribution Simulation Cycle Summary

J Report No. I R1304158-01-00 I Customer: I Bausch & Lomb Page 4 of 17 DOL Inc 10200 Valley V1ew Road Su1te 101 Eden Pra1rie MN 55344 Tel 952-941 9226 Fax 952-941-9318

DOL West 17371 Mount Wynne C1rcle Su1te A Fountam Valley CA 92708 Tel 714 979 1712 Fax 714-979-1721

CONFIDENTIAL 24

Upon completion of the distribution simulation testing some minor damage was observed on the shipper(s), such as scuffing and creasing. This type of damage is common within the distribution environment and is not considered to be a critical defect. The data for the distribution simulation testing is located in Appendix 8 of this test report.

Package Integrity Testing Bubble Leak Testing Forty trays were bubble leak tested per ASTM F 2096-11 and Bausch & Lomb protocol number BLP9490 Rev. A. All packages passed the bubble leak test. The results are shown below:

Test Interval Specimen Number Number of Pass Fail Samples Tested

Post Conditioning I 235498 - 235499 20 Trays 20 0 Distribution Simulation 235501 - 235502 20 Trays 20 0

Table 7: Bubble Leak Test Results

The data for the bubble leak testing is located in Appendix C of this test report.

RELATED DOCUMENTS

Standards

ISTA 3A (2008): General Simulation Performance Test Procedure for Packaged-Products for Parcel Delivery System Shipment 70 kg (150 /b) or Less ASTM F 2096-11 : Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) References

DDL, Inc. Quote# 01304158-04 Bausch & Lomb Protocol# BLP9489 Rev. A: Reusable Injector Handpiece Ship Test Protocol Bausch & Lomb Protocol# BLP9490 Rev. A: Reusable Injector Cartridge Ship Test Protocol DDL, Inc. S.O.P. # 2006-12: Environmental Chamber Test Activities DDL, Inc. S.O.P. # 6011-08: Distribution Simulation Tests

DDL, Inc. S.O.P. # 6047-08: Work Instruction for Bubble Leak Testing

Table 8: Standards and References

I Report No. I R1304158-01-00 Customer: I Bausch & Lomb Page 5 of 17 DOL Inc 10200 Valley V1ew Road SUite 101 Eden Prame MN 55344 Tel 952-941-9226 Fax 952-941-9318

DOL West 17371 Mount Wynne C1rcle Su1te A Fountam Valley CA 92708 Tel 714-979-1712 Fax 714-979 1721

CONFIDENTIAL 25

LOGISTICS

Specimen(s) 235488- 235503 were received on 13 May 2013. Environmental Conditioning:

Started: 24 May 2013 Completed: 27 May 2013

Distribution Simulation Testing: Started: 04 June 2013 Completed: 05 June 2013

Bubble Leak Testing: Started: 06 June 2013 Completed: 06 June 2013

Specimen(s) 235488 - 235503 were returned to Bausch & Lomb on 07 June 2013.

EQUIPMENT/MATERIALS

The following equipment was used to complete these tests:

Equipment Name (Gage ID) Asset No. Calibration Due Climate Chamber 069 004007 12-Mar-14 Thermocouple Probe 002748 19-Feb-14

Climate Chamber 067 004004 07-Feb-14 Thermocouple Probe 001207 19-Feb-14 L.A. B. Accudrop Swing Arm Tester 001030 Verified with ruler Medium Vibration System 002862 08-May-14 Ruler 002701 28-Nov-14

Package Tester 001001 11-Feb-14 Pressure Gauge 002810 05-Nov-13 Equipment Name (Gage ID) Serial No. Calibration Due Temptale4 Sensor (584) 3730290471 24-Jan-14 Temptale4 Sensor (631) 3708391316 25-Apr-14

Table 9: Equipment/Materials List

I Report No. I R1304158-01 -00 Customer: I Bausch & Lomb Page 6 of 17 DOL, Inc. 10200 Valley V1ew Road Suite 101 Eden Prame MN 55344 Tel 952-941-9226 Fax 952 941-9318

DOL West 17371 Mount Wynne C1rcle Su1te A Fountam Valley CA 92708 Tel 714-979 1712 Fax 714-979-1721

CONFIDENTIAL 26

TEST PROCEDURE

Environmental Conditioning Environmental conditioning was performed per Bausch & Lomb protocol numbers BLP9489 Rev. A & BLP9490 Rev. A Sec. 10.1, and DOL, Inc. S.O.P. number 2006-12. The test conditions were as follows:

-10C (+/-soC) at uncontrolled RH for 72 hours minimum (specimen #'s 23S488-23S492 & 23S498 - 23SSOO )

S0C (+/- soC) at 8S% RH (+/- S% RH) for 48 hours minimum (specimen #'s 23S493 - 23S497 & 23SS01 - 23SS03)

60C (+/-soC) at 8S% RH (+/- S% RH) for 24 hours minimum (specimen #'s 23S493 - 23S497 & 23SS01 - 23SS03)

A summary of the environmental conditioning is presented in the results portion of this test report and the data is located in Appendix A

Distribution Simulation Distribution simulation testing was performed per Bausch & Lomb protocol numbers BLP9489 Rev. A & BLP9490 Rev. A Sec. 10.3- 1 0.6, and DOL, Inc. S.O.P. number 6011-08. The packaged product, as described previously, was subjected to the following schedules. Each schedule is described in the order that it was performed during the test. A summary of the distribution simulation testing is presented in the results portion of this test report and the data is located in Appendix B.

I Report No. I R1304158-01-00 I Customer: I Bausch & Lomb Page 7 of 17 DOL Inc. 10200 Valley View Road Su1te 101 Eden Pra1ne MN 55344 Tel 952941 9226 Fax 952-941-9318

DOL West 17371 Mount Wynne C1rcle Su1te A Fountain Valley CA 92708 Tel 714-979-1712 Fax 714-979-1721

CONFIDENTIAL 27

Drop Test The test levels and method for this schedule of the distribution cycle were intended to determine the ability of the shipping units to withstand the hazards occurring during manual handling such as loading , unloading, stacking , sorting, or palletizing. The main hazards from these operations were the impacts caused by dropping or throwing. Size, weight, and shape of the shipping units will affect the intensity of these hazards. The drop heights, the number of drops and the shipping units' orientations at impact performed on these packages are presented below in Table 9.

Drop Height Orientation 18inches 3-4 Edge

3-6 Edge 4-6 Edge 3-4-6 Corner 2-3-5 Corner 2-3 Edge 1-2 Edge

36inches Face 3 Bottom

18inches Face 3 Bottom

Table 10: Test Method ISTA 3A First Drop Sequence.

This procedure was performed using a drop tester.

Figure 3: This photograph shows the setup for the drop test. (18" bottom)

I Report No. I R1304158-01 -00 I Customer: I Bausch & Lomb Page 8 of 17 DOL Inc 10200 Valley V1ew Road Su1te 101 Eden Prame MN 55344 Tel: 952-941-9226 Fax: 952-941-9318

DOL West 17371 Mount Wynne C1rcle Su1te A Fountam Valley CA 92708 Tel. 714-979-1712 Fax 714-979-1721

CONFIDENTIAL 28

Vibration under Dynamic Load (Over-The-Road Trailer Simulation) Overall acceleration levels were 0.53 grms with total test duration of two hours. The package was constrained but not secured to the table for this element of the test. Table 10 below denotes the PSD level for Over-The-Road Trailer Simulation.

Frequency (Hz) PSD (g2/Hz) Frequency (Hz) PSD (g 2/Hz) 1 0.0007 24 0.004 3 0.02 28 0.001 5 0.02 36 0.001 7 0.001 42 0.003 12 0.001 75 0.003 15 0.004 200 0.000004

Over-all Qrms: 0.53 Duration: 120 minutes

Table 11: ISTA 3A Frequency Power Spectral Density Level Over-The Road Trailer Simulation.

This procedure was performed using a vertical linear vibration test system.

Figure 4: This photograph shows the setup for the vibration under dynamic load test.

I Report No. I R1304158-01-00 Customer: I Bausch & Lomb Page 9 of 17 DOL Inc 10200 Valley V1ew Road Suite 101 Eden Prame MN 55344 Tel 952-941-9226 Fax 952-941-9318

DOL West 17371 Mount Wynne C1rcle Su1te A Fountain Valley CA 92708 Tel. 714-979-1712 Fax 714-979-1721

CONFIDENTIAL 29

Random Vibration (Pick-Up and Delivery Vehicle Simulation) Overall acceleration levels were 0.46 gnns with total test duration of thirty minutes. The package was constrained but not secured to the table for this element of the test. Table 11 below denotes the PDS level for Pick-Up and Delivery Vehicle Simulation.

Frequency (Hz) PSD (g 2/Hz) Frequency (Hz) PSD (g2/Hz) 1 0.001 24 0.001 3 0.035 29 0.0001 4 0.035 50 0.0001 7 0.0003 70 0.002 13 0.0003 100 0.002 15 0.001 200 0.00005

Over-all 9rms: 0.46 Duration: 30 minutes

Table 12: ISTA 3A Frequency Power Spectral Density Level Pick-Up and Delivery Vehicle Simulation.

This procedure was performed using a vertical linear vibration test system.

Figure 5: This photograph shows the setup for the vibration test.

I Report No. I R1304158-01-00 Customer: I Bausch & Lomb Page 10 of 17 DOL Inc 10200 Valley Vtew Road SUite 101 Eden Pratne MN 55344 Tel 952-941-9226 Fax 952 941-9318

DOL West 17371 Mount Wynne Ctrcle Suite A Fountatn Valley CA 92708 Tel 714 979-1712 Fax 714-979-1721

CONFIDENTIAL 30

Drop Test This test schedule has been described previously and was repeated on the test specimens. The drop heights, the number of drops and the shipping units' orientations at impact performed on the packages is presented below in Table 12.

Drop Height Orientation 18inches 3-4 Edge

3-6 Edge 1-5 Edge 3-4-6 Corner 1-2-6 Corner 1-4-5 Corner

36 inches Face 3 Bottom

18inches Face 3 Bottom on Hazard

Table 13: Test Method ISTA 3A Second Drop Sequence.

This procedure was performed using a drop tester.

Figure 6: This photograph shows the setup for the drop test (18" bottom on hazard).

I Report No. I R1304158-01-00 Customer: I Bausch & Lomb Page 11 of 17 DOL Inc 10200 Valley Vrew Road Surte 101 Eden Prarrre MN 55344 Tel 952-941-9226 Fax 952-941-9318

DOL West 17371 Mount Wynne Crrcle Surte A Fountarn Valley CA 92708 Tel 714-979-1712 Fax 714 979-1721

CONFIDENTIAL 31

Package Integrity Testing Bubble Leak Test Bubble leak testing was performed per ASTM F 2096-11 and DOL, Inc. S.O.P. number 6047-08. The test method is designed to detect open pathways, channels, or voids across the seal area intended as a primary sterile barrier, and to detect pinholes in non-porous materials. Samples were prepared for testing by cutting a small hole in the tray for connection from the air source to the package. The test apparatus listed in the "Equipment/ Materials" section was used as the air pressure source. A test sample was used to determine the set pressure by using a 0.008 inch wire to create a known defect in the package. The porous package was submerged approximately one inch in a water bath for at least five seconds with no air pressure being applied to the package. The pressure was then increased slowly until a steady flow of bubbles came from the known defect created in the package. This pressure was then used to test the remaining packages. The packages were observed for evidence of leakage in the form of a steady stream of bubbles emanating from the package.

Figure 7: The Bubble Leak Test Set-up

A summary of the bubble leak testing is presented in the results portion of this test report and the data is located in Appendix C.

I Report No. I R1304158-01-00 I Customer: I Bausch & Lomb Page 12 of 17 DOL Inc. 10200 Valley V1ew Road Su1te 101 Eden Prame MN 55344 Tel 952-941-9226 Fax 952-941-9318

DOL West 17371 Mount Wynne Circle Su1te A Fountain Valley CA 92708 Tel 714 979-1712 Fax 714-979-1721

CONFIDENTIAL 32

DISCLAIMER OF WARRANTIES

ALL WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY THAT THE PRODUCT OR PACKAGING TESTED IS MERCHANTABLE, FIT FOR A PARTICULAR PURPOSE, OR IN COMPLIANCE WITH ANY FEDERAL, STATE OR LOCAL REGULATIONS, ARE DISCLAIMED. In no event shall DOL, Inc. liability exceed the total amount paid by Bausch & Lomb for services rendered. A Quality Assurance program should be in place to ensure that the manufacturing process produces products/packages of equivalent performance to those tested here. This is solely the responsibility of the manufacturer. DDL, Inc. takes no responsibility for the quality of products/packages produced hereafter, other than to certify the design of those physical test systems actually tested by DDL, Inc. DDL, Inc. takes no responsibility for the use, acceptance or non-acceptance of this data by government regulatory agencies. In the event of future changes to the referenced test procedure(s), it is the responsibility of Bausch & Lomb to determine whether additional testing is necessary to verify that the product and/or packaging certified here remains in compliance with requirements.

I Report No. I R1304158-01-00 I Customer: I Bausch & Lomb Page 13 of 17 DOL, Inc. 10200 Valley V1ew Road Su1te 101 Eden Pra1ne MN 55344 Tel 952-941-9226 Fax 952-941-9318

DOL West 17371 Mount Wynne C1rcle SUite A Fountain Valley CA 92708 Tel 714-979-1712 Fax 7 4-979-1721

CONFIDENTIAL 33

STATEMENT OF CONFORMITY

DOL, Inc. has completed the above stated testing services performed in accordance to applicable standard good laboratory practices and/or standards identified within this report. Testing has been completed as described herein. The following list of exceptions occurred during testing performed at DOL, Inc.:

None All materials, equipment, methods, and processes used to perform the described testing have been standardized, calibrated, and monitored in accordance with prescribed guidelines, standard operating procedures, and the supervision requirements of DOL, Inc. All raw data obtained from this testing by DOL, Inc. personnel is archived at DOL, Inc.

The signatures below are in compliance with 21 CFR Part 11 .

Testing performed by:

Project Manager:

Technical Approval:

Quality Approval:

Ed J . Kehoe, Ashley D. Hall, Adam D. Stuessel, and Pone

f\klimvan d Digitally signed by Ahmed lssa m e DN: cn=Ahmed lssa, o=DDL, Inc, ou=Operations, email=ahmed.issa@testedandproven.

Iss a Ahmed A. lssa Project Manager

Luke J. Munroe Luke J. Munroe

com,c=US Reason: I am the author of this document Date: 2013.06.11 12:18:21 -05'00'

Digitally signed by Luke J. Munroe DN: cn=Luke J. Munroe, email=luke.munroe@testedandproven .com, o=DDL, Inc., ou=Operations, c=US Reason: I am approving this document Date: 2013.06.11 12:26:02 -05'00'

Packaging Project ManagarDigitally signed by Tammy J. Nelson Tam my DN:cn=TammyJ.Nelson, email=tammy.nelson@testedandpro ven.com, o=DDL, Inc., ou=Administration, c=US J . N e I 50 n :~~~:~~~m approving this

Tammy J. Nelson Quality Specialist

Date: 2013.06.11 13:03:44 -05'00'

I Report No. I R1304158-01 -00 Customer: I Bausch & Lomb Page 14 of 17 DDL Inc 10200 Valley Vtew Road Sutte 101 Eden Prame MN 55344 Tel: 952-941-9226 Fax. 952-941-9318

DOL West 17371 Mount Wynne Ctrcle Suite A Fountatn Valley CA 92708 Tel: 714-979-1712 Fax 714-979-1721

CONFIDENTIAL 34

APPENDIX A: ENVIRONMENTAL CONDITIONING DATA

I Report No. I R1304158-01-00 Customer: I Bausch & Lomb Page 15 of 17 DOL Inc 10200 Valley V1ew Road Swte 101 Eden Prame MN 55344 Tel 952 941 -9226 Fax 952-941-9318

DDLWest 17371MountWynneCircle Su1teA FountanValley CA92708 Tel714-979-1712 Fax 714-979-1721

CONFIDENTIAL 35

Equipment Information

Tesled and Proven.

Customer: Bausch & Lomb Job number: -'"1.;;;..30;;..4....;.1.;;.;58:;...._ ______ _

Customer PO: .;..N::..A:..._ ________ _ Product Tested: .;.;M.;.;:e;,::cd;,::cica=..:.I-=D;,::ce.:..:vic::.:e:;...._ ____ _

Lot Number:.;..N;.;..A;...._ ________ _

Start Date End Date Verified by Equipment Used GageiD Asset Number Calibration Due Date Initials c :r (f)e> Lf

Environmental Conditioning

Taated and Proven. Customer: Bausch & Lomb

Job number: -,:1,;30:::.;4.:..:1..::5:::.8 ________ _ Customer PO: NA

Product Tested: ~M;=e~d,...ic""'at'"'o=-e-VI::-.c-e ______ _ Lot Number:-"N::;A,__ _________ _

Test Cycle/Conditions: -1 DC +/-5C @ Uncontrolled RH for 72hrs mini Profiled by: (If AppH

Equipment Information

Tested and Proven. Customer: Bausch & Lomb

Job number: ..:.1.=.;30::...;4~1::..:58:...._ ______ _

Customer PO: ..;..N::...;A'-----------Product Tested: ..;.;M.;.;:e..::.di;.:;.;ca:;.;.I..;;:D..::.ev.:..:.ic::..:e'-------

Lot Number: ..:..N::..;A;__ ________ _

E

E~voronmental Condition ng

Tealtd and Proven. Customer: Bausch & Lomb Job number: ~1.,::3::.04.;..1;.;5;.::8 ________ _

Customer PO: NA Product Tested: ~M:,:;e:.,d,..IC-8';""1 o=ev-,c-e ______ _

Lot Number: .:.N:::.A;_ _________ _

Test Cycle/Conditions: 50C +/-5C @ 85% RH +/-5% for 48hrs mini 60C +/-5C @ 85% RH +/-5% for 24hrs mini

Profiled by: i.'k /z ~ '1'J?A4f ~t (II Appl~bleJ App;o\/Od By Dalt Program Verification: ~~ 2J lt7Jt'j-/ j (If 1\ppleobla} AppiD'-'Od 13y Dole

Milestonas Date

SOP #2006 Ret. =--~'~z.==--Test Standard: Per B&L Protocols. Sec. 10.1

DaqBoard Verification :~ Digital Outpull :

Overtemp Set Point: Overtemp Vefllicat1on.

Initial Start DatefTime : 17'F.-LLI.UJ~.,L-I-+:..:;~::..LU.:.+--,Pf:.P.:-+--::~..qr-+->o~~----l'"'-1:.4.-"":....L----I ~~~"~"~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ii~~~~~~iJ SEE PROFILE: f C cle End DatefTime :

Specimen #'s 235493-235497, 2355Dr'}.5~D3 t:."'lL ~:.17-'/Y./) Worksheet Approval Approwd By Date

Speclmen(s) Removed . Data Approval

Form # 8232-07 512312013

CONFIDENTIAL 39

APPENDIX B: DISTRIBUTION SIMULATION DATA

I Report No. I R1304158-01-00 Customer: I Bausch & Lomb Page 16 of 17 DOL Inc 10200 Valley V1ew Road SUite 101 Eden Pra1ne MN 55344 Tel 952-941-9226 Fax 952 941-9318

DOL West 17371 Mount Wynne C1rcle Su1te A Fountam Valley CA 92708 Tel 714-979-1712 Fax 714-979-1721

CONFIDENTIAL 40

DOL Job Nil: 1304158 CUSTOMER: Bausch & Lomb

PO Nil: NA PRODUCT NAME: Reusable ln]eclor Handp1ece ShiP Tesl

B&l Praloool: BLPG43i Rev A TEST TYPE: ISTA 3A 2008

PACKAGE TYPE: Standud SOP No.: 6011 R81. No.

DIM: Length: 7 ln. Wkltll: :J ln. Height: 1 112 ln.

SEQ. TDT lEST - NO. CATEGORY TYJII!

1 SHOCK

DROP INDIVIDUAL PACKAGE

'DnHI Tatllf

2 VIBRATION

OVER THE ROAD SPECTRUM

WITHOUT TOP LOAD

Mbndlon Tble -

I 3 VIBRATION PICK-UP & DELIVERY

SPECTRUM WITHOUT ~Tete TOP LOAD

.. SHOCK


[oro, TAler

Initial Drop lfelgtlt (ln.): Stick Height (ln.):

Fntor:

Shlpplftlll wt. (lb1.):

T1IBT IITH8ITY'

18''. Edae I~ 18" Edae 3-6 18'' Ed1111 .C-61

18'' Comer ~-61 18" Comer 2-3-5

18"-Edae 2-3 18" Edllll 12 38" F- 3) 18" Face (3}

18 108

00035

c 20

TL with face 3 down = 11 08-HI X L X W X 0.0035 TL = 1081 51x7 x3x0 0035

8 calcullllad TL Is rounded UD to nexl51b. ~

1 Hour with,_ :s down liD a.u-

Tl with lace oil down = 1()8.W} X l x H x 0.0035 Tl =_tl08-3jx 7 X 1.5 X 1:1.1)035

..

CalcUlated TL Is roundedJII)_IO next 5 lb. 111C1111T111n! 31 Minutes with F-4 down IIIII. A_.,.__

T wllh face 6 down = 1108-t.l X W X H X 0 0035 Tl = 11l8-71x3x1 .5x00035

2 Cek:ullled TL IS rounded UD Ia next 5 lb lnc:nlment

~ Mlnul w11t1 ,_ down e o.u -

~ Minulas wllh ,_ 3 down m D.4&-

18''- Edoe ~ 1 8" Edllll 3-8 18" Ed01 ,15

18'' CQITier (3_.-6 1!1" Comer 12-6 18" Comer 11_.-5

38" FIICe 3 1rF-1lllaDrll ....

PP"11lfl11 pkg. description photos 10 be laken after ISTA tesllng Is complete: J;4Jl.lll Photo of s~rlcortt.tner (lncludng ann wldlfferent dimensions}

-

ISTAJAWorbheel Cold

--JH);I

v t/ v

"' ,

v liP!'. llffl'r_

r'KIA/ v

lQ.M..'V

1 -~~ -

I "f' '\ ~

110'1' ""' ., ., .,

" ltfJ'IC f".llAA

Work.uhoot Approval ~ .. =r :J!~-I.fl

,......... ....... _,_ 231410 231411 ..,

,/ .,/

"' v' ./

"" ,/ ./

v ,/ ../ ". V' ./ "

,/ ./ -~ ..., .,/ . ../. v ./

" \/ .,.

.... v v

\/ ..., /

-

/ .._

, \ -"'

/ v I

v ... / \/

" /

i/ ., v .J

" "" "'

., -./ ~ ..,_ ,. , J

v V"' V"'

Fonn 1182311-{12 R....-By l/llk= Dolo ' /,~"lo(l\~/3

Postv EC

Photo --Z3MI2 -/ ~

./ ./ v v ,/ .,/ .,/ [(Zl;Vl ./ ##17 ::TIA/i

;/_ (1f1:/l/l U!'rH 'J ,

./ rt7't -.,

_., ~ " '!"

./ AoYl"'i! -~ ..

..,. ~ ./ \;1" ., .,. v ./ ..;"

"" ~ ~ MD" 11'1"

Page 1 of1

CONFIDENTIAL 41

DOL Job .. : 1304156 CUSTOMER: Bausch & Lomb

PO .. : NA PRODUCT NAME: ReusaDie ln1eclor Handp1ece Sh p Tesl

B&l PrDtoDOI: BLP948ll Rev A TEST TYPE: ISTA 3A 2008

PACKAGE TYPE: Standard SOP No.: 6011 Rei. No.:

DIM: Lengtll : 7 ln. Wlcfttl : ln. Hllght: 1 112 ln.

SEQ. 11i.8T TEST NO. CATJ!GOIIIY TYPII

1 SHOCK


IDroiiT-

2 VIBRATION

OVER-THE-ROAD SPECTRUM

WITHOUT TOP LOAD

Vlllrdon Tallie

3 VIBRATION PICK-UP & DELIVERY SPECTRUM WITHOUT

IVlllntlon Tallie TOP LOAD

"' SHOCK


IDroiiT-

Initial Drop HIIQht (ln.): St8ok Height (ln.):

Factor:

SlllpplntJ wt. (llle.):

TDT IN1DIITY

19"- EdQtl, ~ 19"-Edoe,J.e 1 8"- Eda. , 4-61

18"- Comer 1~-6 18"- Comer 2-3-S

18"- Eclae !2-3 9" Edoe 11-2.l 38"-F- 3 19"- Face 3

16 106

OOCllS

020

TL with faCIO 3 down = 1011-H\ x X W X 0.0035 TL -'_(1()6.1.5 )X 7 X 3 X 0.0035

9 Calcullltad TL Is rounded uo to next 51b. lncrermmt

1 Hour with F- S down C O.IS .,_

TL with face 4 down - 1 09-Wl x L x H x 0 0035 TL- 108-3 )X 7 X 1.5 X 0.0035

"' Calcula!ad Tl IS rounded UP lo next 5 lb incremanl 31 Minutes with F- 4 down \1111.13 InN

TL with loce 6 down = 108-l X W X H X 0.0035 TL = 109-7 x 3x1.5x00035

2 Celcutatad TL IS rounded UP to next 5 lb. increment

31 Minutes with 1'-1 down c 1.13 -

SO Mint.Ces with F- 3 down 11!11.41 ,,_

1 9"- Edo&l~ 18"- Edoe 3-6 18" Edal 1-5

1 8"- omer 3-4-el 18"- Comtr 1-2-6 18"- Corner (1-4-5)

36"-F- (3) 1rl'- 131 on Huard Bloak

~I pkg. description photos to be taken after ISTA testing Is complete (tlJllll Photo of shtpper/Contan.r (lndudlng ones wlclfl'erent dtrnenlions)

ISTA 3A War!l1/leel HI>!

Dl.a /k?'

/ ,/ ./ ./

" tr 111117

~'7

.)'I"IAA

li->AA.~

'C/AJ...'-J

J'b'JT

-"' ./ ,

"" " ..,

llfllt .:.n/1.1'1

Worktshool Approval

........lluniiMfs DICM :IMGI

\/ -v ./

., ./

a/ .,/ , ;/ ./ ./

V' ./ , ""

"" o/

../ .......

-../ ../

...,.. ~

"\./ v

"" " " "' , ,/ , , J , .., ,.

\/ \/" "'

./

Form 1182J0.02 R- !lr" fJtJr Cote-Uf1~/ _)

Pastv EC

~ i ; a.

i ?

- Pllola --.. Dial 2HQ1 -../"

-t7~\l

"" /

, ~ "

./ ,.

../ ../ / _/ / ../ ./ ~ ..,.. .., 1110 "F 00/IA

A ~ v ;r All (r;;Ifl_

, ...... ~-

/ v r-.-I'H-J

..,./ ..; ~ 'i"

\/ v: t!HJ., 1":n ..,.

,

"" ~

../ .,

./ "

"'

., .,. .... ., ..,.

"" ...,

Jl h +.'.t') i/ .......

- ~

Page 1 of 1

CONFIDENTIAL 42

DOL Job Nil : 1304156 CUSTOMER: Bausch & Lomb

PO Nil : NA

ISTA 3A WOI1tshoot Cold

PRODUCT NAME: Reusable Injector Cartndge Ship Test 8&1 Protocol: BLP9489, Rev A

TEST TYPE: ISTA 3A - 2008 PACKAGE TYPE: Standard

SOP No.: 6011 Rei. No.: DIM: Length: 4 ln.

Width: 3 112 ln. Height 2 114 ln.

SEQ. TEST TEST . NO. CATEGORY TYPE

1 SHOCK


DroDTester

2 VIBRATION


WITHOUT TOP LOAD

Vnntion Table I

3 VIBRATION PICK-UP & DELIVERY SPECTRUM WITHOUT

VIbration Table TOP LOAD

" SHOCK


1~Tea11tr

Initial Drop Height (ln.): Stack Height (ln.):

Factor:

Shipping wt. (lbs.):

TEST INTENSITY

18"- Edae (3__.} 18'- Ecloe (3-6} 18' Edae (4-6)

18"- Comer 13+61 1 B" Comer 12-3-51

18"- Edge (2-3} 111' - Edae (1-2} 38"- Face (31 18"- Face C3l

18 106

0 0035

0 15

TL with face 3 down = (1 08-tj}_X LX W X 0.0035 TL a (108-2 25 )X 4 X 3.5 X 0.0035

8 Calculated TL Is rounded uo to next 5 lb. Increment

1 Hour with Face 3 down a 1.53 anna

TL with face 4 down= (108-Wl x LX H X 0.0035 TL = (108-3.5Jx 4 X 2.25 X 0 0035

" Calculated TL is rounded UD to next 5 lb. increment 30 Minutes with Face 4 down C 8.53 anwa

TL with face 6 down= (108-L} X W x H X 0.0035 TL = {108-4jx 3.5 x 2.25 X 0 0035

3 Calculated TL Is rounded up to next 5 lb. Increment

30 Minutes with FKe I down ft 0.53 nn

30 Minutes with Face 3 down Q 0.41gmta

18'- Ecloe (3-4) 18' Ed!ie (3-8) 18" Edae C1-5l

18"- Comer C3+6l 18"- Comer (1-2-61 18" Comer 11-4-51

38' Faee_i3l_ 1r-Fece lll ttaul'lll Bleck

P~u_ct) pkg. description photos to be taken after 1ST A testing Is complete ~I Photo of shipperkontarnor (Including ones wldiflarant dlmensoons)

Soed!Hn Numbers 235411 2314!11

fff'_' / v' ./ ,/ / ,/ v' ./ ./

" ./ ../ ./ ./ B/)_#1 v ~, ..,

6HAII V"

\./

~..0.'~ \./

( ..rl/1/\ v

II'P7 ~ or v

" ,

./ ,

./ o/ ./ o/

ffi,HJ v (KY./ v

Form 18230.02 Reviewed By /l4z; Date 6=-Zl l(tt-1)

Poslv EC

PltoCo _ ......

23A88 - ., 'rJAI\""

, ...

....

,

./

./ v v f~A/l ,/' lfll'? IJtiAA

All

""""' r-KTAA rern

'./

i./ {~/.J.-,

v ~ "

v RB., ~:)

.., -to:"~ ""

V"

./ ../ ..,

v_,. I !V i'Y::L

....... H"'J lfiTI" i

Page 1 of1

CONFIDENTIAL 43

ISTA 3A Worksheet Hot

DOL Job Nl: 1304158 CUSTOMER: Bausch & Lomb

PO Nl: NA PRODUCT NAME: Reusable lnJeclor Cartndge Shrp Test

B&l Protocol: BLP9490. Rev A TEST TYPE: ISTA 3A- 2008

PACKAGE TYPE: Standard SOP No.: 6011 RJ. No.:

DIM: Length: 4 ln. Width: 3 1/2 ln.

Height: 2 1/4 ln.

SEQ. TEST TEST , NO. CATEGORY TYPE

1 SHOCK


DrooTester

2 VIBRATION


-

WITHOUT TOP LOAD

M brltion Table I.

3 VIBRATION PICK-UP & DELIVERY SPECTRUM WITHOUT IVnw.t~on Table TOP LOAD -

4 SHOCK


IDroo Tester

Initial Drop Height (ln.): Steck Height (ln.):

Fec:tor:

Shipping wt. (lbl.):

TEST IIITEIIIIn

18"- Edge (341 18"- Edge (3-8) 18"- Edge (4-6)

111"- Corner 13-4-6) 18"- Corner 12-3-51

18"- Edoe 1231 18"- Edge (1 -2) 38" Face C3l 18"- Face 13>

18 108

0.0035

0 .15

TL with face 3 down= 1108-HI XL x W x 0.0035 TL = 1108-2.25 IX 4 X 3.5 X 0.0035

8 Calculated TL Is rounded up to next 5 lb. increment

1 Hour with Face 3 down ft 8.53 anne

TL with face

ISTA 3A Control & Input Data C:\TTV2\DmdProRnd\ISTA 3A_AutoSave_2013-06-04_13-52-09.DRN

TestQ 10: ISTA 3A Profile ID: ISTA 3A Over-the-Road 1 Hour

Ch 1

PSD (G2/Hz)

1

0.1

0.01

0.001

0.0001

1e-005

1e-006

= = -

-

-

r-

= ~/ ~ 1-r-1-1-r-

= ~/ ~ -

-

;-,__

,__

f= = 1--,__

1--'-

~ 1--1---

1-

/

/

1e-007 1 2

Medium Vibration Table

Control: 0.536 G nns Demand: 0.528 G nns - 100.0%

/ \ 1\ \ I\

I I

/ 1\ \ \

Company Name: Bausch & Lomb -1304158 Orientation: Face 3

Elapsed: 1 hr 0 min 1 sec Remaining : 0 hr o min 0 sec

I I

I

10 20 Frequency (Hz)

I

\

\

I

L

1:52:08 PM Jun-04-2013

Profile: 1 of 1 Total : 0 hr 0 min o sec

\

\

\ !\ :\~ ll,_\ \ \ 1\ I

:\' \ \ ' 1\ 'I

\ 100 200

CONFIDENTIAL 45

ISTA3A Control & Input Data C:\TTV2\DmdProRnd\ISTA 3A_AutoSave_2013-06-04_14-40-01 .DRN

TestQ 10: ISTA 3A Profile 10: ISTA 3A Over-the-Road 30 min

Control: 0.546 G nns Demand: 0.528 G nns- 100.0%

Ch 1

PSD (G2/Hz)

1

0.1

0.01

0.001

0.0001

1e-005

1e-006

= = -

-

- /

~/ v ~ -

-

-

-

- /

~/ v ~ f-r-1-r-r-

-

f= ~ r-

~ r-r-

~

~ r-

~ 1-1-

1e-007 1 2

Medium Vibration Table Company Name: Bausch & Lomb -1304158 Orientation: Face 4

1\ \ !\

\ l ' \

\ ~ \ I i\

Elapsed: o hr 30 min o sec Remaining: 0 hr 0 min o sec

I I

--

I


I

\

\

1/

I . r

I

Profile: 1 of 1

2:40:01 PM Jun-04-2013

Total : 0 hr 0 min o sec

I

\ 1\

\ I \ 1!\

I I

\

\ '

1\ \ 1\ \

\

100 200

CONFIDENTIAL 46

ISTA3A Control & Input Data C:\TTV2\DmdProRnd\ISTA 3A_AutoSave_2013-06-04_15-18-22.DRN

TestQ 10: ISTA 3A Profile 10: ISTA 3A Over-the-Road 30 min

Control: 0.534 G rms Demand: 0.528 G rms- 100.0%

Ch 1 1 = ;::: c-

~ r-

0.1

r- / f= / ~/

~ -0.01 -

-

-

-

-

0.001 / =

PSD (G2/Hz)

0.0001 ~/ v ~ ~ r-

~ ~

1e-005 1---r= r-

~ r-

~ 1-

1e-006 I= ~ t-r-r-t-

1e-007 1 2

Medium Vibration Table Company Name: Bausch & Lomb -1304158 Orientation: Face 6

\ \

I\ 1\ I I I

1\ \ \

I

Elapsed: 0 hr 30 min 0 sec Remaining: 0 hr 0 min 0 sec

I


I

\

\

I

I

[1

3:18:22 PM Jun-04-2013

Profile: 1 of 1 Total : 0 hr 0 min 0 sec

\ I\

\1 !\ I \ \ ~ \ 1\.\ \ \ \ 1\ l \ \ \ 1\

\ 100 200

CONFIDENTIAL 47

ISTA 3A Control & Input Data C:\TIV2\DmdProRnd\ISTA 3A_Auto5ave_2013-06-04_16-13-27 .DRN

TestQ 10: ISTA 3A Control: 0.464 G rms Profile 10: ISTA 3A Pick-Up and Delivery 30 M1 Demand: 0.458 G rms- 100.0%

Ch 1

PSD (G2/Hz)

1 ~ I= f-t--

-

-

0.1 t= -

-

-

-

-

-

~ .....

0.01 r-.....

1-f-

f-

0.001 ~ 1-f-

f-f-

f-

0.0001 f= ~ f-f-f-

1e-005 c--= -

-

-

-

-

1e-006 1

Medium Vibration Table

-

1/

I t---

2

Company Name: Bausch & Lomb -1304158 Orientation: Face 3 - 2

\ \

\ \ ~

I

1\

Elapsed: 0 hr 30 min 0 sec Remaining: 0 hr o min o sec

I -

I


I I

\ \

Profile: 1 of 1

4:13:27 PM Jun-04-2013

Total: 0 hr 0 min o sec

I !\ 1/

/t I 1 I \ \ 1/ ,-\

/ \

100 200

CONFIDENTIAL 48

APPENDIX C: BUBBLE LEAK DATA

I Report No. I R1304158-01-00 Customer: I Bausch & Lomb Page 17 of 17 DOL Inc 10200 Valley View Road, Su1te 101 Eden Prame MN 55344 Tel. 952-941-9226 Fax 952 941-9318

DOL West 17371 Mount Wynne Circle, Suite A Fountain Valley CA 92708 Tel 714-979-1712 Fax 714 979-1721

CONFIDENTIAL 49

0-

Tested and Proven

Bubble Leak Test Cold

Post EC/ISTA 3A

DOL Job N: 1304158 Customer: Bausch & Lomb

PO N: NA w o ,-kshee"t App,-oval . -'~'"""'~--'~~~~'

Product Name: Reusable Injector Cartridge B&L Protocol: BLP9490, Rev. A Package Type: Single Barrier Tray

Package Tested: Tray w/Tyvek Lid

Equipment Used: Pressure Delivery System Asset#: 00 /&O I

Cal Due Date: // - ;-~ b - /~ Pressure Gauge

Asset #: 0 () ;;;_~to Cal Due Date: \S- t{t:7V- ! 3

DOL SOP#: 6047 Tes7'-t -=-st:-a-nd7 a-r-:-d:-ASTM F 2096-11

Notes Spec1men Sample Results Sample Prep C A/ 235498 1 ~ Pass

2 ...!:::::: !Pass t{2{l~ "Dia. Gauge 3 E Pass

4 ~ 'Pass Was Blocking Agent Used: 5 2 Pass Yes or @circle one) 6 --.;;;;- Pass

7 1::::: Pass 8 ~ Pass 9 ~ Pass 10 ~ Pass l

I 235499 11 -=:.:: rPass l 12 -v Pass I

Bubble Failure Locations 13 ~ Pass Tyvek Side Up. 14 ~ Pass

15 ....1.::::::: Pass

16 o/ Pass I 17 z Pass 1

A 18 17'" Pass 19 !2 Pass 20 ~ Pass ' B

Reviewed By: __ ,_,flth;:........,:::...._ __ Date:

Form# 8105-06

Tes-t Technician

Rei#:

Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail

T e s1 D a"te s (J~~--:-;:-""-"'!.-fE:d-::-:---PM (ino"toals)

Machine Parameters Flow Rate : 0 !]?12 ~ Pressure : CJ /G PSI

Pressure Verification : C N

Comments/Location of Leak pkg test photo V" (D

I I

I I

I I

I I

C>r / _) I u I l)

\"'i- / ,.z, I Joo., ,,

l !.tY I I -' \

I IYV I

I v

I pkg des.

photo~

page 1 of 1

CONFIDENTIAL 50

(j

Tested and Pronn.

Bubble Leak Test Hot

Post ECIIST A 3A

DOL Job N: 1304158 Customer: Bausch & Lomb Workshee-t Approval : ~ ( 0 \l l"Q "l/.> ~ fOote)

PO N: NA Product Name: Reusable Injector Cartridge B&L Protocol: BLP9490, Rev. A Package Type: Single Barrier Tray

Package Tested: Tray w/Tyvek Lid

Equipment Used: Pressure Delivery System Asset#: 06(0 a I

Cal Due Date: --11.;;,.--,E=-e..-b~---:/,....,.lf-,:--Pressure Gauge

Asset #: 60 ,2. 8;- I 0 Cal Due Date: --5==---_....,)./(j-=;;;..v...,-~1-=--...3-

DOL SOP#: 6047 Tes..::t -=-st-=-a-nd-=-a-r-=-d :- ASTM F 2096-11

Notes Spec1men Sample Results Sample Prep C M 235501 21 \... F"ass

22 z Pass c{)O

DDL Tested and proven.

Vision Statement DOL will become the preferred worldwide supplier of professional services in its chosen

areas of product, package and material testing , design and consulting.

Mission Statement To continually strive to exceed our customer satisfaction by providing accurate data,

attention to detail and quick turn-around times by using DOL's quality system, responsive project management and exceptional customer service.

DOL, 'IV..::r 17371 MI. Wynne Circle, Suite A

Fountain Valley, CA 92708 tel: 714.979.1712 1 800.229.4235

fax: 714.979.1721

DOL, '7 ...... 10200 Valley View Road, Suite 101

Eden Prairie, MN 55344 tel: 952.941.9226 1 800.229.4235

fax: 952.941 .9318

www.testedandproven.com

CONFIDENTIAL 52


Attachment 4- Visual Inspection

CONFIDENTIAL 53


Document Number: BLP9490 Revision: A Page 13 of 15

Attachment 3

Visual Inspection

Hot Temperature Condition Cold Temperature Condition

Sample Pass (P) I Comments Sample Pass (P) I Comments Fail (F) Fail (F) 1 r ~ 1 r '0 2 p \ 2 ? \ 3 r \ 3 (' \ 4 p \ 4 p \ 5 r vf~ 5 f Yl{q 6 f I \ 6 p \ 7 1> \ 7 ? \ 8 f \ 8 1> \ 9 \> \ 9 r \ 10 r \ 10 -p \)

Acceptance Criteria: Refer to section 12.0 of this protocol .

Comments: __ _.~----------------------

Performed By I Date: Verification Results:

CONFIDENTIAL 54


Attachment 5- Lens Delivery

CONFIDENTIAL 55

L Title: Reusable Injector Handpiece Ship Test Document Number: BLP9489 Revision: A Page 20 of 20

Attachment 5

Functional lens Delivery

ow o 1- ' 1S: "' +to . .:: ,Ac;)ol..)3

Acceptance Criteria: Refer to section 12.0 of this protocol.

Comments: 11d

Performed By I Date: --Jr-..,.::~~V_0_1/__;~;.._ ____ _ Verification Results: ~ Pass [] Fail

31 'f +'?>4" AOD08'2.

32 7> -+ ~'fo Ae1uueo 33

'P -\- 3Jf. 0 A-ovo~ 34 p .f ~'/-0 ArJUo5q

35 ~ -p t 3'"1 0 Aoov ;=f (

36 ? .f lj'f C) Auo0B'6 37 ? f3'f.v AovvS 8 38 P> --t ~Lf.o _A-c.vu;::;-&.r 39 ~ i ~ .lf CJ A-uu -:ls r 40 p -f 5'-f c) AvO'e3 -:f- /I"'Wr'er/1'1 lf"'S-# 3219-3!!>002. jN.S de.(tv~w;J

t:l"d (Jit-7.> ovn~ ~d(. {1~ .. lflte rx'"'"' ~... +rr LJ(;J c>6~ ... vt"c:/ . Ho!.Vl'lll'~ , ~~-- ~ DF&/~#1'"'7"k # s;~?o608 orq 1./-J/-..re~

r~~5'~d ;;;:"X"Jd .... fl cfo/ivrt-.., _

CONFIDENTIAL 56

BAUSCH LOMB~ NUMBER: BLP9489 I REV. A I PAGE 1 OF I TYPE: Deviation Form LOCATION: Aliso Viejo, CA TITLE: Reusable Injector Handpiece Ship Test

DEVIATION FORM

This form is to be used to document deviation(s) noted during the execution of the protocol. Duplicate as required. A separate form is to be used to address each deviation. Other details may be attached if necessary. Deviation No.: 001 I Protocol Section No.: 11 .1 I Page No.: nla

PROTOCOL REQUIRMENTS State the protocol requirements:

Per the Reusable IOL Delivery System DFU: "Rotate the handpiece knob clockwise to advance the plunger. Ensure that the plunger tip engages the lens and remains behind the lens throughout the entire delivery until the lens is fully released into the eye."

DEVIATION Describe the deviation:

During the functional lens delivery section of the 'Post Ship Test Inspection', plunger tip override was observed on lens sample #35 (serial number: 3217315002). The plunger tip rode on top of the lens optic approximately 0.5 to 1.0 mm but was able to advance and exit the lens from the inserter with the plunger tip over the lens optic. However per the DFU, the user is to ensure that the plunger remains behind the lens until the lens fully exits the inserter tip.

Documented By: Will Sea j Date: 12-Jun-2013 DEVIATION RESOLUTION

0 No corrective action required; justification explained below or attached. 181 Corrective action required: D Documentation correction only 181 Retest item D Retest section(s) D Protocol Addendum required

Justification or corrective action to be implemented:

Lens #35 (serial number: 3217315002) was inspected for cosmetics immediately after delivery which showed the optic edge to have an imprint mark in the area that the plunger tip contacted. After 18 hours at room temperature, the lens was allowed to relax to it's original properties and the imprint mark was no longer present rendering the lens acceptable per FP-3243. Note that per ISO 11979-3:2006 Section 5: "After release from the deformed state, allow the lens to relax at in situ conditions up to 24 h 2 h."

d /'/ Prepared By I Date: Will Sea I Approved By I Date: Troy Painton

_/// /2;/(lfo/2-0f_S

SUMMARY OF CORRECTION ACTION

Due to lens #35 (serial number: 3217315002) not remaining in front of the plunger tip during lens delivery, the sample was not used as part of the functional delivery testing data and was replaced with lens serial number 3350608019 and retested. The operator ensured that the plunger tip remained behind the lens during the delivery and the post-cosmetic delivery acceptance criteria was met.

Acceptance Criteria Met?: 181 Yes DNa Approved By I Date: Troy Painton 4~ (Z.:JvCU"Zo\,l'

...

Approved By I Date:

CONFIDENTIAL 57

AVC Surgical Testing Laboratory

TP-8261 I Functional Delivery Testing

BAUSCH + LOMB TO D..,.:!' .. c,,--a.:---t 1""\-r: --."T'--a.:-- lA- : __ --\ 1-"'' - See better_ Live better

CONFIDENTIAL 58

r---

ISO 11979-3 I 4.12 - Surface and Bulk Homogeneity (Cosmetics) Test Set-up

Protocol ~ails E"qui~ment Details I Test Details lll'JiiOCOIHNumber BLP9489 'Microscobe ID EO- CJS"C:. Parameter =- S~ifieac=J L :=1rciiii1~ IT:esttRoint Ship Study GaugetaH L31.8LJ n/a 3344963009 Po._t~ C319D nla 3344963013 Pa..s~ 0 200 n/a 3344962041 ?ASS 21 n/a 3344962038 PIA~ S c:::.r220 nla 3344962039 'PAl.S 23 n/a 3344962037 'Pal~ 24 n/a 3350122002 P~>ls 0250 n/a

n/a 1\ I 26 '

n/a n/a I CJ271 n/a n/a .,, ~ 28 n/a n/a I 29 n/a nla v 30 n/a

FP-3216 Akreos Global Cosmetic Inspection Criteria FP-3219 Silicone IOL Cosmetic Criteria FP-3243 enVista Lenses Global Cosmetic Criteria

Pass/ -Sample IOLSerial@ I= ail (flgh) r.. 31 3343748012 \' 32 3343748014 \ L 33L 3343746016 \ 34 3219316009

35 -3217815992 it'-t1{~ 36 3219316016

I ~37.] 3343749020 \ 38 3219316017 \ 39 3219316008 \ L1J.a'J 3219316005 \ L~j1[l n/a \ 42 n/a \ 43 nla

44 nla 45 n/a

* "33506o5 o l~

BLR7989 Installation Qualification for the Cosmetic Inspection Microscope System

Acceptance Crieria Met

Pass/ Completed By Fail Print I Sign/ Date ' EA~_s.. I(..W.A-o-11.\ Pl.4.4-~'-""

P IA'H ~ ?as~ "1=>-'li'i b- AO _,!. I Pa s.s

f'Gl~> ~at.S Pt. ~~ Pt;'u _Q_~ I~

\ n/&.

\

\J

YES _L )!( NO I 0

Check One I RmewedBy: ~q /o-i~~ I

BAUSCH + LOMB TP-R?R1 ... l=unl"tinn:al r\oli\fanr TOC!t inn /Arnu5e-"" Char-\ /17n\ vl ... v " - - -,., -6 Co See better. live better.

CONFIDENTIAL 59

H.c..,Jputt> .$(1rlal

('"\

Functional Delivery Testing

Completed By:

Test Execution

r~=k!l. - Labeled Fold Unfold Fold ~Outcome Sbing ~Cosmetics Completedhl IOL Serial # Power Start ~ Duration ~ fDJ fHR:MINJ fHR:MINJ (M/NJ (Pass I Fall) , (#) (Pass/FaD) Print I Sign I Date 16 n/a :\ nla n/a nla r nla ~ 17 n/a n/a n/a nla \ nla 18' n/a n/a nla n/a n/a 19 nla n/a nla nla nla ()6 - t l( - 1 ~

0 200 nla n/a nla nla nla 21 n/a nla n/a nla nla J ,22 nla t1141 nla n/a nla n/4 n/a h/1

u 2au nla nla n/a n/a n/a ~ I 24 n/a n/a nla n/a nla 25 n/a n/a n/a nla nla 0 260 n/a nla nla n/a n/a l 0~70 nla n/a n/a n/a nla 0 280 n/a nla nla nla n/a I 29 n/a nla n/a nla n/a ~3QC_] nla \1. nla n/a nla '/ nla ct References: TP-8261 IOL and Insertion Device Fold & Recovery and Functional Delivery Testing

FP-3242 IOL and Insertion Device Fold & Recovery and Functional Delivery Criteria Acceptance Crleria Met ~ ?

YES I ~ NO I 0

Check One --------

I RevlewedBy: _____:-;~ /c--::r ... -:;~-~ / ._ Sign Date

BAUSCH + LOMB TD DI')C .. e . . --A: ---1 M-1:. .--. T - -!-- l A- .. : _ _ r-11 .- ~ ,,._,.. ~ - c;,.,. hPthr I iv,. hPttPr

CONFIDENTIAL 61

H"""f,.,_IR $e.1.4ol ~

Aoe~o~-z.. ,4-0CIO B" rtuuu55" J4-0vV 5"1 A-ooo71 1'\cJ"" ~& ,Aa Print / Sign Date

~ (High) I , 0 3110 0 320

33 I 34 I 35 I 36

37 0 380 C]39'D CI4t:lD 0 4i'ID

42 c::I43D I J:~L 1

45

References:

Test Execution Labeled Fold Unfold Fold Delivery~ String IOL Serial I Power ~ Time Duration Count (D) lHR:MiNJ (HR:MINJ (MINJ (Pass / Fall) (I),

-

3343748012 i-3+U n/a nla n/a ":>~ nla 3343748014 ~?.Y.o n/a n/a n/a ~r'> n/a 3343746016 +~u n/a n/a n/a R>JS n/a 3219316009 ~ >lf,C n/a n/a nla p~.s n/a 3211816QQ2 If +~If.() nla nla nla ?~ n/a 3219316016 -B.If.u n/a n/a nla ~ nla 3343749020 B'fo nla n/a nla {?.> n/a 3219316017 -+3~. 0 n/a n/a nla ~.F5 nla 3219316008 -+ >lf-CJ n/a n/a n/a ?'5" nla 3219316005 4- ~.if. C) nla nla nla P'J') nla

n/a "'

nla n/a n/a "l nla nla J n/a nla n/a I nla n/a Vl(q nla n/a nla ~ nla nla I n/a nla nla I nla nla v n/a nla nla \J.... nla -~

.- --- a

TP-8261 IOL and Insertion Device Fold & Recovery and Functional Delivery Testing FP-3242 IOL and Insertion Device Fold & Recovery and Functional Delivery Criteria

T~tDetails Specified

per Protocol or~ ~ 3min s 20 min

F~~ (Pass I Fall) .:v~ ?n-.r . f.?rrr

-~

~?'$" . tffxr

~-~;>'" 2.$'S" ~.P.S ..,

( ill~ I

J.,

Acceptance Crieria Met ----. J--~

Actual '8/35 Pi' ~c.

n/a

! -

Completed By Print I Sign I Date

f-l~ TP--11--rJ ~~ 1'6 --I 0 - t?

'

~

YES I ).. NO I D

Check One I Reviewed By: ~ ,/0-U'

~

ISO 11979-3 I 4.12- Surface and Bulk Homogeneity (Cosmetics)

Completed By:

Test Execution (POST Functional Delivery) ~l IOL !~,# "[D!j Sample ~LSeriaiJ Pass/ Sample t IOL{SHru# I 1P~ Completed By ean (Mkl} Fail {1-fgh) JF.iill. Print / Sign / Date ~1C":J 3344962036 Po~us 0 1:6---=:J n/a 0 3J1D 3343748012 f>t::\~S. lc.IIA-"'1-4 PIIA~

2 3344963012 Pe~lc;. 17 nla 32 3343748014 'PetS.~ 3 3344963006 Pa~ ~tao n/a 33 . 3343746016 Pa~s

-

4 3344963009 _E>Q_.s_..s L 3l9L 1 n/a 34 3219316009 Pel~5 6 . 10 .11] 5 3344963013 P~u~ [_1200 n/a nit< .35 -9217'S~5992 f _-= ~

' * c=I6U 3344962041 Po~s 21 n/a 36 3219316016 Pa.s~~ WS" 6/t.ft~ c::Jr7t=l 3344962038 f'a.H 0 22L n/a [_l3l1'C 3343749020 1't~.)S

8 3344962039 'P~H 0 231 n/a 38 3219316017 PtuC. 9 3344962037 Pros 24 n/a 39 3219316008 VtiS\

10 3350122002 A::ljj 0 250 nla \ll 40 3219316005 _1:>(;'tS. 01~10 n/a 26 n/a til C 7 4JiCl n/a ~ 0 1'20 n/a 27 nla I 42 n/a I c=5f3D nla 28 n/a WA 43 n/a 111M

14 nla 29 n/a I 44 n/a L 15 n/a D r:J n/a v ~ 450 n/a 11:1 .

.. ,,. .

-*" 5d-pk 3-~ v~pf,tpJ. ""/ sj,AI : -a?-5"060 Sol"l 01-(.L -lu /e .. s owvvo.k. /:-1-- -the. 'l>F-U ' ;/ rt-r.... "Jt,p y , d .. s De,'{'-- ;~,s o;:r/'c

s-/rJp If'" t:/d n4/ c:/~RV"'- '7'k (ehS .

References: FP-3216 Akreos Global Cosmetic Inspection Criteria FP-3219 Silicone IOL Cosmetic Criteria FP-3243 enVista Lenses Global Cosmetic Criteria BLR7989 Installation Qualification for the Cosmetic Inspection Microscope System

Acceptance Crieria Met 1[ --:35"""=-="=""f ""'"!3.-::-3. -:=5"::-::0~6-:tJ-::::~:-o~/ """"C,_,.:-rt -;:R:;-~--:-~-:-? -,t 't- ,_t" "1}

YES I X. NO I 0

Check One I ReviewedBy: ~ /O-:J~---;.,~ 1

Sn ~~

BAUSCH + LOMB TP. R?R1 - ~unl"tinn~l r1aliuant Ta~tinn IA'"utro,.. Diu~ \ 117n\ vl~v See better. live better.

CONFIDENTIAL 63


Attachment 6- Bubble Leak

CONFIDENTIAL 64


Document Number: BLP9490 Revision : A Page 14 of 15

Attachment 4

Bubble leak - Post Transit Data Sheet

Temperature Condition: Temperature Condition: 60!!C 2!!C with 85% 5% RH -lO!!C 2!!C with uncontrolled RH

Sample Pass (P) I Fail (F) Comments Sample Pass (P) I Fail (F) Comments 1

'P ~/A 1 l' ,J~ 2 v rV/4- 2 p /VIA 3 p N!A 3 p tV/h 4 rp

-tJ Jtr 4 f II/A 5 7 /I)/A 5 p #/h 6

'P tV/It 6 -p lf//1} 7

'P tJ/4 7 :p 11/11 8

'P A)/A- 8 :p AJ/11 9

'P IJ)It 9 p )1/IJ 10 1' r/JP- 10 "-P rV llr


Comments: ________ __.~~--------------

Performed By I Date: _ _......LAJ~i-4----'tQ"'---...:.j~U:.:.:n..:..-...... 1..::;~---Verification Results: lir'ass [] Fail

CONFIDENTIAL 65

L Title: Reusable Injector Cartridge Ship Test Document Number: BLP9490 Revision : A Page 15 of 15

Bubble leak- Post Transit Data Sheet

Temperature Condition: Temperature Condition: 602C 22C with 85% 5% RH -102C 22C with uncontrolled RH

Sample Pass (P) I Fail (F) Comments Sample Pass (P) I Fail (F) Comments 11 :p tV/A 11 t> tV/11 12 f> IV/A 12 'P til~ 13 f AJJA. 13 I> AJ/4 14 p #/JJ 14 p !VIA-15 p #lA 15 p dJ!t 16 f 111111 16 p N/A 17 'P AIJJJ 17 ':p AliA 18 ~ #LA 18 ? fliL4 19 1' r/111 19 'P 111/~ 20 =r !'1/ll 20 ~ d/11


Comments: ________ ~AI;,..cll;.;.'ll-.:....... _____________ _

Performed By I Date: C/1) p .. QU.Vl--1 3 Verification Results: ~ass [] Fail

CONFIDENTIAL 66


Document Number: BLP9490 Revision: A Page 1 of 15

sc 0 Global Packaging Engineering

Rochester, NV

Reusable Injector Cartridge Ship Test Protocol

BLP9490

Prepared By: /~(l*f![zog Troy Painton


Approval Signatures I Dates Project Manager: Sushant Muchhala Date:

Global Packaging Manager: Brian B xton . K_ c:ff Date: ~/1' / (J ~ ..lir'""\ /

-~ ,

-





Supplier Quality: Joe Melnick Date:


CONFIDENTIAL 67

B L Title: Reusable Injector Cartridge Ship Teet Document Number: BLP9490 Revlelon: A Pqe 1 of 15

A Global Packaging Engineering

Rochester, NY


BLP9490

Prepared By: d~(-*A(zotf Troy Pointon



D&R Engineering: Will Seo Date: /tf-

Date: 5 f t EMO: Randy Woods Date:

Global Quality: Date:

Date: /(, Medlcel: Tobias Maler Date:

CONFIDENTIAL 68

. I ~ Reusable Injector Cartridge Ship Test Document Number: BLP9490 I Revision: A I Page 1 of 15

{ I ,. . ' ! i l ' ' : . r

Global Packaging Engineering Rochester, NV


BLP9490

Prepared By: / ~lt#AftIS' Troy Pointon


- IS c Project Manager: Sushant Muchhala Date:




J

EMO: Randy Wood~_ ~A ~ /LR-

Date: 5" -/6 -/..J Global Quality: Sanaz S~tode~ Date: Supplier Quality: Joe Melnick Date:


CONFIDENTIAL 69

B L Title: Reusable Injector Cartridge Ship Test Document Number: BLP9490 Revision: A Page 1 of 15

AUSCH 0 Global Packaging Engineering

Rochester, NV


BLP9490

Prepared By:-----------Troy Pointon








Supplier Quality: Joe Melnick /} Date:

Medicel: Tobias Maier / {AUk \

CONFIDENTIAL 70

B Title: Reusable Injector Cartridge Ship Test Document Number: BLP9490 Revision: A Page 2 of 15

Table of Contents

1 INTRODUCTION 4 2 PURPOSE 4 3 SCOPE 4 4 DEFINITIONS, ACRONYMS, AND ABBREVIATIONS 4 5 REFERENCES 4 6 RESPONSIBILITIES 5 7 PRE-REQUISITES AND GENERAL REQUIREMENTS 5 8 SAMPLING PLAN AND RATIONALE 5 9 TEST SAMPLE PREPARATION 6 10 TEST PROCEDURE 6 11 POST SHIP TEST INSPECTION 9 12 ACCEPTANCE CRITERIA 9 13 PRODUCTION DISPOSITION 9 14 DEVIATIONS TO THE PROTOCOL 10 15 ATTACHMENTS 10

CONFIDENTIAL 71

B+ L Title: Reusable Injector Cartridge Ship Test Document Number: BLP9490 I Revision: A I Page 3 of 15

REVISION HISTORY

Revision No.

Revision History Author

Original Document T. Painton

Date

5/16/2013

CONFIDENTIAL 72


1.0 INTRODUCTION

This protocol will evaluate the proposed packaging configuration for the AX-Xl reusable injector cartridges for Project ROSOl ability to withstand the anticipated distribution hazards.

2.0 PURPOSE

This transportation test will provide documented evidence the reusable injector cartridge packaging configuration protects the product when exposed to the hazards of normal handling, storage and distribution per ISTA 3A standard .

This transportation test will provide documented evidence of compliance with applicable IS0-11607-1:2009 requirements.

3.0 SCOPE

This verification is limited to the AX-Xl reusable injector cartridges being developed under B&L Project ROSOl. Cartridges are manufactured and packaged at Medicel.

4.0 DEFINITIONS, ACRONYMS, AND ABBREVIATIONS

Name Description AVC Bausch & Lomb Aliso Viejo, CA B&L Bausch and Lomb oc Celsius (in degrees)

DOL Distribution Dynamic Labs ISTA International Safe Transit Association N/A Not Applicable

No. or# Number P/N Part Number PC Procedural Choice RH Relative Humidity

SOP Standard Operational Procedure % Percent

5.0 REFERENCES


ASTM F2096-11 Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) Viscoject l.S Cartridge Medicel control card for Building Axiom IOL Delivery System Xl

Set instructions, Rev. 00 Cartridge Viscoject 2.2 Cartridge Medicel control card for Building Axiom IOL Delivery System Xl

Set instructions, Rev. 00 Cartridge

CONFIDENTIAL 73

B L Title: Reusable Injector Cartridge Ship Test Document Number: BLP9490 Revision: A Page 5 of 15


ISTA 3A-2008 Packaged-Products for Parcel Delivery System Shipment 70kg {1501b) or less FP-3244, Rev F enVista MX60 IOL

ISO 11979-5:2006 Ophthalmic implants-- Intraocular lenses

6.0 RESPONSIBILITIES

Group Responsibilities ;

B&L Global Packaging Writing the protocol and final summary report Arranging for testing at the ship test facility

Medicel Test sample builds B&LAVC Functional Lens Delivery

DOL- Testing Subjecting test samples to the conditioning and test parameters Laboratory Returning test samples to B&L Aliso Viejo, CA

7.0 PRE-REQUISITES AND GENERAL REQUIREMENTS

Training- Current Good Manufacturing Practices for Medical devices shall be followed throughout the execution of the protocol. Operators will be trained and training will be documented in the training form in this protocol and the applicable SOPs prior to performing their assigned tasks.

Process Equipment- No new computer systems or processing equipment are being implemented that would require validation before the procedure in this protocol is executed. Measurement equipment shall be appropriate for the attributes being measured and capable of providing meaningful and valid results. Calibrated inspection equipment used during the execution of this protocol will be documented in the final report.

Process Materials/Components- Materials and packaging components for this study will be inspected, approved and released for use per standard Medicel procedures before they are utilized in this study. The manufacturing plant will document all materials and components used in this study by part number. Lot numbers for all components will be documented in the final report.

8.0 SAMPLING PLAN AND RATIONALE

Sample size of six (6) cartons, sixty (60) cartridges in total, will be used to for this testing. Hot and cold environmental conditioning will be conducted on three {3) carton test samples at each condition. Functional lens delivery testing will be included as part of the acceptance criteria . Ten lenses will be delivered for each environmental condition parameter to satisfy the minimum requirements of ISO 11979:2006. enVista MX60 lenses with various diopters will be used for functional lenses delivery. AX-R1 Handpieces from BLP9489 will be used for lens delivery .Handpiece serial numbers will be recorded in the lens delivery datasheets. Lenses delivery will be captured in BLP9489 datasheets and will be included in BLP9490 report.

9.0 TEST SAMPLE PREPARATION

CONFIDENTIAL 74


The following procedures will be followed for protocol execution:

9.1 Build and package sixty (60) cartridges per Medicel control card Viscoject 1.8 and 2.2 Cartridge Set instructionsfor Axiom IOL Delivery System X1 Cartridge

9.2 Place packaged cartridge samples into over shipper. Label outside of shipper with BLP9490.

9.3 Ship test samples to test facility at the address below via expedited air I truck shipment:

DDL, Inc. 10200 Valley View Road, Suite #101 Eden Prairie, MN 55344

10.0 TEST PROCEDURE

The following procedures will be followed for protocol execution:

10.1 Upon receipt of test sample at the test facility, the test samples will be removed from its over-packaging and subjected to each of the following environmental conditions for no less than 72 hours.

#of Cartons I Test Condition Temperature I RH Duration I J

3 Cold -10C 5 I Uncontrolled Relative 72 hours Humidity +50C 5 I 85% 5 Relative Humidity 48 hours

3 Hot Then +60C 5 I 85% 5 Relative Humidity 24 hours

The total time exposed will be included in the report from test laboratory.

10.2 Identification of test sample faces, corners, and edges:

4---y 5

10.3 Drop Sequence: 9 drops will be performed per ISTA 3A as indicated in the following:

CONFIDENTIAL 75


10.4 Random Vibration: Random vibration will be completed per ISTA 3A as indicated in the following:

NOTE: No top load weight is required based on the top load calculations are less than 2Sibs.

FreqLncy PSD Level, (!h) g'/Hz 1 0 0.0007 3.0 0.02 50 002 70 0001 12.0 0 001 150 0004 24.0 0.004 280 0001 36.0 0.001 420 0.003 75.0 0.003

2000 0.000004 10 IDO

Frequency, Hz.

10.5 Random Vibration : Random vibration will be completed per ISTA 3A as indicated in the following:

CONFIDENTIAL 76


ISTA 3A Pick-up and Delivery Vehicle Spectrum 0.1 Freq.~ency PSO Level,

(Hz) g'/Hz 10 0.001 ~0 0035 .t.O 0.035 i .O 00003 BO 00003 15.0 0.001 :!tO 0.001 23.0 00001 5).0 0.0001 n.o 0002 10.0 0002 2(00 0 00005

10.6 Drop Sequence: 8 drops will be performed per ISTA 3A as indicated in the following:

10.7 Upon completion of the ISTA 3A procedure, the 1 carton from each environmental conditioning group will be overnight delivered to B&L:

Attention: Sushant Muchhala Bausch + Lomb 30 Enterprise, Suite 450 Aliso Viejo, CA 92656

Remaining 2 cartons from each environmental conditioning group will be bubble leak tested per ASTM F2096-11.

11.0 POST SHIP TEST INSPECTION

CONFIDENTIAL 77


11.1 The following evaluations will be executed post ship testing at B&L Aliso Viejo:

Product Inspection: Evaluate 10 cartridges (1 carton) from each temperature condition. Visually inspect carton label legibility, carton, DFU, and sealed cartridge packaging for damage under normal office lighting conditions. Document the results in Attachment 3 datasheets.

Functional Lens Delivery: Following product inspection deliver 10 lenses, one per cartridge, from each temperature condition. Verify dimensional acceptance per the following:


FP-3244

Drawing Number

BL000024661,Rev.A BL000024653,Rev.A


O.OD to +4.0D +lO.OD to +34.0D

Results will be documented in BLP9489 Attachment 4 datasheet.

11.2 The following evaluations will be executed