Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular Lens
Phase: NA
Conditions: Cataract, Corneal Astigmatism
Sponsor: Johnson & Johnson Surgical Vision, Inc.

 
 
Study Protocol 
 
 
Clinical Investigation of Rotational Stability of the 
TECNIS® Toric II Intraocular Lens 
 
NCT Number: NCT04327518 
Document date: 10 Aug 2020 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                          CONFIDENTIAL 
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CONFIDENTIAL 
The following contains confidential, proprietary information  
that is the property of Johnson & Johnson Surgical Vision 
Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular 
Lens  
 
PROTOCOL NUMBER:  NXGT-202-QROS 
 
SPONSOR:  Johnson & Johnson Surgical Vision, Inc. 
1700 East Saint Andrew Place 
Santa Ana, CA 92705 
714-247-8200 
 
Investigator Agreement 
 
As an Investigator, I agree to: 
• Implement and conduct this study diligently and in strict compliance with this 
agreement; the protocol; Good Clinical Practices; ISO 14155 and all other 
applicable regulations; conditions of approval imposed by the reviewing 
Institutional Review Board (IRB); Ethics Committee (EC); FDA and other regulatory 
authorities; and all other applicable laws and regulations. 
• Supervise all testing of the device where human subjects are involved. 
• Ensure that the requirements for obtaining informed consent are met. 
• Obtain authorization for use/disclosure of health information (e.g., HIPAA 
authorization or equivalent). 
• Maintain all information supplied by Johnson & Johnson Surgical Vision in 
confidence and, when this information is submitted to an independent IRB, EC or 
any other group, it will be submitted with a designation that the material is 
confidential. 
 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
 
 
 
 
Investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
Date 

JOHNSON & JOHNSON SURGICAL VISION                                                                                          CONFIDENTIAL 
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TABLE OF CONTENTS 
Table of Contents .......................................................................................................... ii 
Personnel and Facilities............................................................................................... iv 
1. 
Synopsis ........................................................................................................... 13 
2. 
Background/Introduction ................................................................................ 16 
3. 
Clinical Hypothesis .......................................................................................... 17 
4. 
Study Design .................................................................................................... 17 
5. 
Acronyms ......................................................................................................... 17 
6. 
Study Objectives and Endpoints .................................................................... 19 
6.1 
Primary Endpoint ............................................................................................. 19 
6.2 
Other Endpoints ............................................................................................... 19 
7. 
Study Products ................................................................................................ 20 
7.1 
Intraocular Lenses ........................................................................................... 20 
7.2 
Implantation Systems ...................................................................................... 22 
8. 
Study Population ............................................................................................. 22 
8.1 
Inclusion Criteria (all criteria apply to both eyes) .............................................. 23 
8.2 
Exclusion Criteria (all criteria apply to both eyes) ............................................. 23 
9. 
Investigator Selection ...................................................................................... 24 
9.1 
Investigator Qualifications ................................................................................ 24 
9.2 
Investigator Obligations ................................................................................... 24 
9.3 
Investigator Approval ....................................................................................... 25 
10. 
Experimental Plan ............................................................................................ 26 
10.1 Overview ......................................................................................................... 26 
10.2 Visit Schedule .................................................................................................. 27 
10.3 Preoperative Procedures ................................................................................. 28 
10.4 Study Lens Supply ........................................................................................... 30 
10.5 Selection of the IOL ......................................................................................... 30 
10.6 Operative Procedures ...................................................................................... 30 
10.7 Postoperative Procedures ............................................................................... 33 
10.8 Exit Of Subjects ............................................................................................... 35 
10.9 Unscheduled Visits .......................................................................................... 36 
10.10 Protocol Deviations .......................................................................................... 37 
11. 
Adverse Events and Product Complaints ...................................................... 37 
11.1 Adverse Event Definitions ................................................................................ 37 
11.2 Product Complaint/Device Deficiency Definition .............................................. 39 
11.3 Adverse Event and Complaint Reporting Requirements .................................. 39 
11.4 Causal Relationship ......................................................................................... 40 
11.5 Adverse Event Follow-up ................................................................................. 41 
12. 
Protocol Changes/Amendments ..................................................................... 41 

JOHNSON & JOHNSON SURGICAL VISION                                                                                          CONFIDENTIAL 
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13. 
Ethics Review and Patient Welfare ................................................................. 42 
13.1 Institutional Review Board (IRB) ...................................................................... 42 
13.2 Informed Consent ............................................................................................ 42 
14. 
Documentation ................................................................................................. 42 
14.1 Source Documents .......................................................................................... 42 
14.2 Subject Confidentiality ..................................................................................... 43 
14.3 Case Report Form Completion ........................................................................ 43 
14.4 Study Summary ............................................................................................... 43 
15. 
Monitoring ........................................................................................................ 44 
15.1 Data Monitoring ............................................................................................... 44 
15.2 Administrative Monitoring ................................................................................ 44 
16. 
Medical Monitoring .......................................................................................... 45 
17. 
Publications ..................................................................................................... 45 
18. 
Risk Analysis ................................................................................................... 45 
19. 
Records Retention ........................................................................................... 46 
20. 
Termination of the Investigation ..................................................................... 47 
21. 
Statistical Methods .......................................................................................... 47 
21.1 Analysis Population ......................................................................................... 47 
21.2 Primary Endpoint ............................................................................................. 48 
21.3 Other Endpoints ............................................................................................... 48 
21.4 Interim Reports ................................................................................................ 49 
21.5 Sample Size Calculations ................................................................................ 49 
Appendix A: Summary of Procedures Required at Each Visit ................................. 50 
Appendix B: Equipment List ....................................................................................... 51 
Appendix C: Instructions for capturing photos through the surgical microscope . 52 
Appendix D: Instructions for using M&S system ...................................................... 53 
Appendix E: Instructions for distance visual acuity testing..................................... 54 
Appendix F: Maximum Plus Manifest Refraction Technique with 
Cylinder Refinement ............................................................................. 55 
Appendix G: Refraction adjustments for visual acuity testing ................................ 56 
Appendix H: Slit Lamp Exam Ratings ........................................................................ 57 
Appendix I: Slit Lamp Retroillumination Photographs ............................................. 59 
Appendix J: Instructions For Lens Axis Measurement With A Slit lamp ................. 61 
Appendix K: Patient Satisfaction Questionnaire (PSQ) ............................................ 62 
Appendix L: Investigator Satisfaction Questionnaire (ISQ)...................................... 63 
Appendix M:  Adverse Event and Complaint Reporting Instructions ...................... 64 
Appendix N: American Academy of Ophthalmology Task Force Consensus 
Statement on Adverse Events for Intraocular Lenses ....................... 65 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                          CONFIDENTIAL 
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PERSONNEL AND FACILITIES 
SPONSOR 
 
 
Johnson & Johnson Surgical Vision, Inc. (JJSV) 
1700 East Saint Andrew Place 
Santa Ana, CA 92705 
 
SPONSOR PERSONNEL 
 
 
 
Medical Safety Officer, Medical Affairs 
Johnson & Johnson Surgical Vision, Inc. 
1700 East Saint Andrew Place 
Santa Ana, CA 92705 
 
 
 
Global Medical Director - Cataract 
Johnson & Johnson Surgical Vision, Inc. 
1700 East Saint Andrew Place 
Santa Ana, CA 92705 
 
 
 
Head of Global Clinical Science 
Johnson & Johnson Surgical Vision, Inc. 
1700 East Saint Andrew Place 
Santa Ana, CA 92705 
 
 
 
Director, Clinical Operations, Surgical Vision  
Johnson & Johnson Surgical Vision, Inc. 
1700 East Saint Andrew Place 
Santa Ana, CA 92705 
 
 
 
Sr. Principal Clinical Research Scientist 
Johnson & Johnson Vision, Inc. 
1700 E. St. Andrew Place 
Santa Ana, CA 92705 
 
 
 
ger, Clinical Research 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                          CONFIDENTIAL 
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Research Fellow, Biostatistics and Data Management 
 
 
EMERGENCY TELEPHONE NUMBERS 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                       
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Protocol Change History 
Version 
Section(s) 
Page(s) 
Description of Change(s)  
Rationale for Change(s) 
1.0 
N/A 
N/A 
Original 
N/A 
2.0 
Sponsor Personnel 
4 
Added Medical Safety Officer 
Updated sponsor personnel to include 
Medical Safety Officer 
1 Synopsis: Clinical 
Hypothesis 
10 
Changed the primary endpoint timepoint from 3-months to 1-
week and specified that the requirement for preoperative 
astigmatism is corneal astigmatism 
Updated to align with the planned timepoint 
for analysis for the primary endpoint and 
provided clarification preoperative 
astigmatism requirement. 
1 Synopsis: Number of 
Subjects; 8 Study Population 
11, 19 
Changed the timepoint for the target to achieve 
approximately 100 bilaterally-implanted subjects available for 
analysis from 3-months to 1-week. Number of subjects was 
changed from approximately 20 subjects to approximately 15 
subjects. 
Updated to align with the planned timepoint 
for analysis for the primary endpoint and the 
planned number of subjects to be enrolled 
per site. 
1 Synopsis: Evaluation 
Criteria 
12 
Added the word “the” in the first sentence and changed the 
primary endpoint timepoint from 3-months to 1-week 
Grammatical change and updated to align 
with the planned timepoint for analysis for 
the primary endpoint 
1 Synopsis & 8.1 Inclusion 
Criteria 
11, 19 
Pre-existing corneal astigmatism of one diopter or greater; 
Corrected error with the inclusion criteria 
1 Synopsis: Exclusion 
Criteria; 8.2 Exclusion Criteria 
12, 20 
Added planned monovision as an exclusion criterion. 
To clarify the refractive requirements for the 
study. 
1 Synopsis: Data Analysis 
12-13 
Changed the primary endpoint timepoint from 3-months to 1-
week.  Provided clarification that the percent of eyes with 
misalignments will also be reported for all other 
postoperative timepoints (1-day and 3-months) 
Updated to align with the planned timepoint 
for analysis for the primary endpoint and 
provided clarification for other endpoint data 
at other postoperative timepoints. 
5. Acronyms 
14-15 
Added ADE, BSS, UADE and USADE.  Corrected spelling 
error for HIPAA. 
ADE, BSS, UADE and USADE were missing 
from the list of Acronyms and the acronym 
for HIPAA was incorrect.  
6 Study Objectives and 
Endpoints; 6.1 Primary 
Endpoint; 6.2 Other 
Endpoints 
15-16 
Changed the primary endpoint timepoint from 3-months to 1-
week.  Provided clarification that the 3-month visit will be the 
key timepoint for visual acuity, manifest refraction and 
patient and investigator reported outcomes questionnaire 
evaluations and that other timepoints will be provided as 
supportive analysis. Changed Percentage of eyes that 
achieve UCDVA of 0.3, 0.2, 0.1 & 0.0 logMAR to 20/40, 
Updated to align with the planned timepoint 
for analysis for the primary endpoint and 
provided clarification for other endpoint data 
at other postoperative timepoints. 

JOHNSON & JOHNSON SURGICAL VISION                                                                       
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20/32, 20/25 & 20/20. Changed Percentage of eyes with lens 
axis misalignments < 5º to ≤ 5º. 
2.0 
7.1 Table 1 Intraocular lens 
18 
Table 1 revised  
Table 1 revised to match DFU 
9.3 Investigator Approval 
22-23 
Deleted Clinical Investigator Brochure Signature Page and 
Hospital/Ambulatory Surgery Center Clinical Study 
Acknowledgement from the list of documents to be signed 
and returned to JJSV. 
The Clinical Investigator Brochure is not a 
requirement for this study since the IOLs are 
marketed product.  The Directions for Use is 
applicable for this study. Also removed 
Hospital/Ambulatory Surgery Center Clinical 
Study Acknowledgement to reflect current 
practice. 
10.1 Experimental Plan, 
Overview 
23 
Grammatical changes to 2nd and 3rd paragraph.  Also deleted 
slit lamp from the procedures that will be done at the 
operative visit. 
To correct grammatical changes and to 
reflect revised protocol requirements for 
procedures to be done at the operative visit. 
10.2 Visit Schedule 
23 
Deleted foot note “a” from the 3-month visit. 
Foot note “a” was initially referenced at the 
3-month visit in error.  This deletion corrects 
the error. 
10.3 Preoperative Procedures 
23-25 
• 
Deleted Uncorrected Distance Visual Acuity from the 
procedures that should be done at the Preoperative Visit 
and provided clarification regarding additional 
preoperative information that should be collected. 
Made correction to IOL model (from ZCT to ZCU);  
To correct typo in original version 
10.6 Operative Procedures 
26-28 
• 
Provided clarification regarding additional procedures 
that can’t be performed during surgery.  Also referenced 
Appendix for instructions for capturing photographs 
through the surgical microscope. 
Implant Instrument Used – added implant instruments that 
are approved to be used in the study.  Specified that BSS 
will be collected on the case report form.  
Some of the implant instruments that are 
approved for use in the study were 
inadvertently not included in Version 1.0 of 
the protocol.  Also clarified that BSS solution 
used will be recorded in the case report 
form. 
10.7 Postoperative 
Procedures  
29-31 
• 
Provided clarification regarding postoperative 
procedures for uncorrected distance visual acuity 
testing, manifest refraction, best corrected distance 
visual acuity and biomicroscopic slit lamp photographs 
and lens axis orientation.   
• 
Provided clarification regarding training requirements for 
individuals performing slit lamp exams and photography.  
To provide clarity for the testing 
requirements for uncorrected distance visual 
acuity, best corrected distance visual acuity 
and manifest refraction at the postoperative 
visits. 

JOHNSON & JOHNSON SURGICAL VISION                                                                       
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Section(s) 
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• 
Added the requirement for the Investigator Satisfaction 
Questionnaire to be completed at the 1-week visit.   
• 
Updated letters for the Appendix references to reflect 
the updated appendices. 
• 
Added details regarding handling secondary surgical 
interventions in the study 
Added details regarding the use of M&S System for 
uncorrected distance visual acuity, best corrected distance 
visual acuity and manifest refraction testing. 
2.0 
10.8 Exit of Subjects 
32 
• 
Added slit lamp photographs of IOL position to the list of 
data that may be collected at an unscheduled visit.  
Also, clarified that fundus exam can be dilated or 
undilated. 
• 
Provided clarification regarding the procedures that are 
required to be completed if a greater degree of rotation 
is noted since last study visit and IOL repositioning is 
required. 
Clarified instructions for handling surgical complications and 
discontinued subjects.  
To clarify subject exit procedures and 
requirements. 
10.9 Unscheduled Visits 
33 
• 
Added slit lamp photographs of IOL position to the list of 
data that may be collected at an unscheduled visit.  
Also, clarified that fundus exam can be dilated or 
undilated. 
• 
Provided clarification regarding the procedures that are 
required to be completed if lens axis orientation had 
changed since last study visit and IOL repositioning is 
required. 
Updated the method of estimating the amount of rotation and 
clarified requirements for completing an unscheduled visit for 
a second eye 1-day or 1-week visit if the first eye is 
examined.  
To provide clarity regarding the 
requirements for estimating the amount of 
rotation and completion of unscheduled 
visits for a second eye 1-day or 1-week visit 
if the first eye is examined. 
10.10 Protocol Deviations 
33 
Updated to reflect that protocol deviations will be 
documented in the Clinical Trial Management System. 
Corrected to reflect the planned process for 
handling protocol deviations. 
 
11.1 Adverse Event 
Definitions 
34 
Updated letters for the Appendix references to reflect the 
updated appendices.  
To provide the correct Appendix references. 

JOHNSON & JOHNSON SURGICAL VISION                                                                       
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2.0 
23 Statistical Methods 
43-45 
Updated the timepoint for the rotational stability endpoint and 
specified that the 3-month timepoint is the key timeframe for 
other endpoints. 
Updated to align with the planned timepoint 
for analysis for the primary endpoint and 
provided clarification for other endpoint data 
at other postoperative timepoints. 
23.1  Analysis Population 
44 
Provided clarification regarding the analysis population and 
available axis data.  Also provided clarification on how data 
will be handled if a repositioning or lens removal procedure 
is required. 
To provide clarity regarding the analysis 
population and situational data. 
23.2  Primary study endpoint 
44 
Updated the timepoint from 3-months to 1-week for the 
primary endpoint 
Updated to align with the planned timepoint 
for analysis for the primary endpoint 
23.3 Other Endpoint 
45 
Updated to reflect the revised timeframes for other endpoint 
data. 
Updated to align with the planned timepoint 
for analysis for the other endpoint data 
Appendix A 
46 
Updated to reflect that pupil size will be collected at all 
postoperative visits, complications/adverse events will also 
be collected at preoperative visits, and the Investigator 
Satisfaction Questionnaire will be completed at the 1-week 
visit. 
Updated to align with study procedures per 
the revised protocol. 
Appendix B 
47 
Equipment list. This appendix was formerly Slit Lamp Exam 
Ratings. 
Added to provide clarity regarding study 
equipment. 
Appendix C 
48 
Instructions for capturing photos through the surgical 
microscope.  This appendix was formerly Slit Lamp 
Retroillumination Photographs. 
Added to provide instructions for capturing 
photographs through the surgical 
microscope. 
Appendix D 
49 
Instructions for Using the M&S System.  This appendix was 
formerly American Academy of Ophthalmology Task Force 
Consensus Statement on Adverse Events for Intraocular 
Lenses 
Added to provide instructions for using the 
M&S System. 
Appendix E 
50 
Instructions for Distance Visual Acuity Testing.  This 
appendix was formerly Instructions for adverse event and 
complaint reporting 
Added to provide instructions for performing 
distance visual acuity testing. 
Appendix F 
51 
Maximum Plus Manifest Refraction Technique with Cylinder 
Refinement.  This appendix was formerly Patient Satisfaction 
Questionnaire (PSQ) 
Added to provide instructions for maximum 
plus manifest refraction technique with 
cylinder refinement 
Appendix G 
52 
Refraction Adjustments. This appendix was formerly 
Investigator Satisfaction Questionnaire (ISQ) 
Added to provide instructions for refraction 
adjustments. 

JOHNSON & JOHNSON SURGICAL VISION                                                                       
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Section(s) 
Page(s) 
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2.0 
Appendix J 
57 
Instructions for Lens Axis Measurement with Slit Lamp 
Updated appendix letter to reflect the appendix number in 
this revision of the protocol and updated the process for axis 
measurement. 
Simplified the instructions for axis 
measurement estimation.   
Appendix B, C, D, E, F, G, H, 
I, J, K, L, M, N 
47-61 
Updated letters of each appendix to reflect additional 
appendices. 
To provide the correct Appendix letters in 
order. 
3.0 
Sponsor Personnel 
4 
Added Head of Global Clinical Science; updated title for 
Director, Clinical Operations, Surgical Vision 
Updated sponsor personnel to include Head 
of Global Clinical Science and to clarify title 
for Director, Clinical Operations, Surgical 
Vision 
1 Synopsis: Overall Study 
Design 
13 
Updated number of sites to up to 8 sites; clarified that 
refractive target outcomes will be emmetropia for each eye 
enrolled in the study; updated visit schedule to address 
either bilateral or unilateral subjects. 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 
1 Synopsis: Study Population 
Characteristics 
14-15 
Updated to allow for unilateral or bilateral enrollment in the 
study; updated the total number of subjects to be enrolled in 
the study, percentage of eyes from unilateral and bilateral 
subjects, and the expected number of subjects per site; 
updated the inclusion criteria to allow for unilateral or 
bilateral enrollment; updated the exclusion criteria to exclude 
enrollment of eye designated for near correction in subjects 
with planned monovision correction. 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 
1 Synopsis: Study Visits and 
Procedures 
16 
Included clarification that the ICF will include designation as 
to whether one or both eyes are to be included in the study; 
clarifies that PSQ is only for bilaterally implanted subjects. 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 
4 Study Design 
17 
Updated number of sites and total number of subjects to be 
enrolled in the study for unilateral or bilateral cataract 
surgery. 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 
6.2 Other Endpoints 
19 
Clarifying that PSQ is only administered to bilateral subjects. 
Updated procedures due to study design 
change. 
8 Study Population 
22 
Updated number of sites, total number of subjects to be 
enrolled in the study, percentage of eyes from unilateral and 
bilateral subjects, and the expected number of subjects per 
site; updated that subjects will be included for unilateral or 
bilateral cataract surgery. 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 

JOHNSON & JOHNSON SURGICAL VISION                                                                       
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8.1 Inclusion Criteria 
23 
Updated to allow for unilateral or bilateral enrollment 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 
8.2 Exclusion Criteria 
24 
Updated to exclude enrollment of eye designated for near 
correction in subjects with planned monovision correction. 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 
10.1 Experimental Plan 
Overview 
26-27 
Updated number of sites and total number of subjects to be 
enrolled in the study for unilateral or bilateral cataract 
surgery; percentage of eyes from unilateral and bilateral 
subjects; corrected the analysis time point to 1-week; 
clarified that PSQ is only administered to bilateral subjects. 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 
10.2 Visit Schedule 
27-28 
Updated to account for bilateral or unilateral subjects: for 
bilateral subjects, 3-month visit window is based on the 2nd 
eye operative date; added footnote to Table 2 to clarify 
instructions on bilateral 3-month visit. 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 
10.3 Preoperative Procedures 
29-30 
Clarifying that preoperative procedures are to be performed 
for each enrolled eye; removed restriction for monovision. 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 
10.6 Operative Procedures 
30 
Updated to allow for MIGS (minimally invasive glaucoma 
surgery) following consultation with the medical monitor. 
Allowing for more standard of care 
procedures to be done with consultation 
with medical monitor. 
10.7 Postoperative 
Procedures 
33, 35 
Clarifying that Binocular UCDVA should be done for bilateral 
subjects only; clarifying that PSQ is only administered to 
bilateral subjects. 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 
21 Statistical Methods 
47 
Adding that data from other study visits other than key 
timeframe may be reported for supportive analysis. 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 
21.1 Analysis Population 
48 
Updated analysis to reflect changes due to unilateral or 
bilateral enrollment. 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 
21.5 Sample Size calculation 
49 
Updated text to reflect sample size was calculated for 1-
week instead of 3-months. 
Updated to align with time frame for primary 
endpoint. 
Appendix A 
50 
Updated footnotes to specify which procedures are 
applicable only in subjects bilaterally implanted with the 
study lens (binocular UCDVA and PSQ). 
Updated to align with the study design 
change to allow for unilateral or bilateral 
enrollment. 

JOHNSON & JOHNSON SURGICAL VISION                                                                       
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Appendix B 
51 
Updated equipment list to allow for a loan of a slit lamp 
compatible with slit-lamp camera. 
To reflect current sites’ equipment needs. 
3.0 
Appendix F 
55 
Removed Snellen and added M&S System to study Manifest 
Refraction procedure instructions.  
Correction to procedure instructions as M&S 
System will be utilized to collect study 
Manifest Refraction. 
Appendix J 
61 
Updated instructions for lens axis measurement with slit 
lamp to use the limbus as a reference mark rather than the 
pupil. 
Correction made to align with practical 
methods used by sites as pupil sizes may 
not be equal between each eye. 

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1. 
SYNOPSIS 
PROTOCOL: 
Clinical Investigation of Rotational Stability of the TECNIS® Toric II 
Intraocular Lens   
Protocol Number:  NXGT-202-QROS 
STUDY LENS: 
TECNIS Toric II – One-Piece Aspheric Acrylic Monofocal Posterior 
Chamber IOL (Model ZCU). 
STUDY OBJECTIVE: 
The purpose of this clinical study is to evaluate the rotational stability 
of the TECNIS Toric II IOL. 
CLINICAL HYPOTHESIS: 
TECNIS Toric II IOL will demonstrate excellent rotational stability by 
demonstrating ≤ 5º of axis misalignment from the intended IOL axis 
of orientation in 90% of eyes at the 1-week postoperative visit, in 
patients with preoperative corneal astigmatism. 
OVERALL STUDY DESIGN: 
Structure: 
Prospective, multi-center, single-arm, open-label 
Number of sites: 
Up to 8 sites  
Duration: 
Three months 
Indication:  
The TECNIS Toric II 1-Piece posterior chamber lenses are indicated 
for the visual correction of aphakia and pre-existing corneal 
astigmatism of one diopter or greater in adult patients with or without 
presbyopia in whom a cataractous lens has been removed by 
phacoemulsification and who desire improved uncorrected distance 
vision, reduction in residual refractive cylinder, and increased 
spectacle independence for distance vision. The device is intended 
to be placed in the capsular bag. 
Administration: 
Refractive target outcomes will be emmetropia for each eye enrolled 
in the study. Surgeons will perform standardized, small-incision, 
cataract surgery and implant the study lenses using a JJSV-
validated insertion system qualified for use with TECNIS Toric II 
lenses as specified in the Directions for Use (DFU).  
Visit Schedule: 
Subjects will be implanted with the study lens in one or both eyes; in 
bilateral subjects the second eye is to be implanted within one-month 
of the first eye surgery. All eyes of all subjects will undergo a 
minimum of 5  to a maximum of 8 scheduled visits:  Preoperative for 
both eyes; Operative each eye, 1-day each eye, and 1-week visits 
for each eye; and a 3-month visit for one or both eyes. 
 

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STUDY POPULATION CHARACTERISTICS: 
Condition: 
Unilateral or bilateral cataracts with corneal astigmatism of 
approximately 1.0 D to 6.0 D.  
 
Models ZCU 1.50, 2.25, 3.00, 3.75, 4.50, 5.25. 6.00 
Number of Subjects: 
Up to 192 subjects will be enrolled to achieve 200 evaluable eyes at 
the 1-week visit with a target of 75% of the eyes coming from bilateral 
subjects and 25% of the eyes coming from unilateral subjects.  
Each site should enroll approximately 24 subjects and no site may 
enroll more than 25% of the enrollment total.  
Inclusion Criteria 
1. Minimum 22 years of age; 
2. Unilateral or Bilateral cataracts for which cataract extraction and posterior chamber IOL 
implantation have been planned; 
3. Pre-existing corneal astigmatism of one diopter or greater; 
4. Predicted residual refractive cylinder based on toric IOL calculator, considering surgically 
induced astigmatism (SIA) and posterior corneal astigmatism (PCA) must be ≤0.50 D; 
5. Potential for postoperative BCDVA of 20/30 Snellen or better; 
6. Clear intraocular media other than cataract in each eye; 
7. Availability, willingness and sufficient cognitive awareness to comply with examination 
procedures and study visits; 
8. Signed informed consent form (ICF) and health insurance portability and accountability act 
(HIPAA) authorization; 
9. Ability to understand and respond to a questionnaire in English. 
Exclusion Criteria: 
1. Irregular corneal astigmatism; 
2. Any corneal pathology/abnormality other than regular corneal astigmatism or corneal 
instability due to contact lens wear; 
3. Previous corneal or intraocular surgery; 
4. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, 
etc.); 
5. Any pupil abnormalities (non-reactive, fixed, or abnormally shaped pupils); 
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7. Recurrent severe anterior or posterior segment inflammation or uveitis; 
8. Subjects with conditions associated with increased risk of zonular rupture, including 
capsular or zonular abnormalities that may lead to IOL decentration, including 
pseudoexfoliation, trauma, or posterior capsule defects; 
9. Known ocular or systemic disease  that, in the opinion of the investigator, may affect visual 
acuity or require surgical intervention during the course of the study, [macular 
degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), 
uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant 
severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related 
cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.]; 
10. Use of systemic or ocular medications (e.g., Flomax)  that may affect vision including prior, 
current, or anticipated use during the course of the study that may, in the opinion of the 
investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or 
a lack of adequate iris structure to perform standard cataract surgery); 
11. Patient is pregnant, plans to become pregnant, is lactating or has another condition 
associated with the fluctuation of hormones that could lead to refractive changes; 
12. Concurrent participation or participation within 30 days prior to the preoperative visit in any 
other clinical study. 
13. Planned monovision correction (eye designated for near correction) 
NOTE: Physicians considering enrolling a patient with one or more of the conditions listed under 
the warning or precaution in the final approved labeling of the device should weigh the potential 
risk/benefit ratio before enrollment. 
EVALUATION CRITERIA: 
The purpose of this clinical study is to evaluate the rotational stability of the TECNIS® Toric II IOL.  
Rotational stability of the IOL will be evaluated by measuring axis misalignment, which is defined 
as the absolute difference between intended IOL axis of orientation (immediately at the end of the 
surgery) and follow-up visit(s) as measured by a photographic based method.  
PRIMARY ENDPOINT  
The primary outcome for the study is the percentage of eyes with ≤ 5º axis misalignment from the 
intended IOL axis of orientation at the 1-week visit. 
DATA ANALYSIS: 
Rotational stability of the IOL will be evaluated by measuring axis misalignment, which is defined 
as the absolute difference between intended IOL axis of orientation (immediately at the end of the 
surgery) and follow-up visit(s) as measured by a photographic based method.  For the primary 
endpoint the percentage of eyes with ≤ 5º of axis misalignment from the intended IOL axis of 
orientation at the 1-week postoperative visit along with the 95% confidence interval will be 

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reported.  The percent of eyes with misalignments ≤ 5º, < 10º, < 20º and >30º will also be reported 
for all other postoperative timepoints (1-day and 3-months).   
 
 
 
 
.  
For visual acuity and refractive data, descriptive statistics will include the mean, standard deviation, 
median, minimum and maximum.  For visual acuity, the frequency and proportion of eyes achieving 
each acuity line will also be reported. The frequency and proportion of eyes within 0.5 D and within 
1.0 D of intended values will also be determined for postoperative refractive cylinder and spherical 
equivalent.   
For questionnaire data, the frequency and proportion with each rating for each item will be 
reported. In addition, the frequency and proportion of eyes with medical findings, lens findings, 
complications and adverse events will also be reported.   
STUDY VISITS AND PROCEDURES: 
Subject eligibility will be assessed at the preoperative visit according to the inclusion/exclusion 
criteria.  The ICF and HIPAA must be signed by any patients who agree to participate in the study 
prior to undergoing any study-specific procedures. This will include designation as to whether one 
or both eyes are to be included in the study. Those subjects who meet the inclusion/exclusion 
criteria and agree to participate will be implanted in one or both eyes with the study lens.  All 
subjects are intended to have either unilateral or bilateral cataract surgery with the second-eye 
surgery occurring no more than 30 days after the first eye surgery.   
Key preoperative data include ocular health and history, pupil measurement, visual acuities, 
keratometry, intraocular pressure (IOP), biomicroscopic slit lamp findings, fundus exam findings 
and biometry. The operative visit will include standard procedures for cataract surgery and IOL 
implantation as well as photographic image of the IOL position, slit lamp exam, complications and 
adverse event assessment.  Key postoperative data include photographic image of the IOL 
position, manifest refraction, uncorrected distance visual acuity (UCDVA), best-corrected distance 
visual acuity (BCDVA), Slit Lamp findings, non-directed visual symptoms, 2-item Patient 
Satisfaction Questionnaire (PSQ), 3-item Investigator Satisfaction Questionnaire (ISQ) and 
adverse events. The PSQ will only be administered on subjects bilaterally implanted with the study 
lens.    
2. 
BACKGROUND/INTRODUCTION 
Approximately a third of patients presenting for cataract surgery are likely to have at least 1.0 D of 
corneal astigmatism.1 Patients with astigmatism that desire spectacle independence after cataract 
                                               
1 Hoffmann PC, Hütz WW. Analysis of biometry and prevalence data for corneal astigmatism in 23,239 eyes. J 
Cataract Refract Surg. 2010;36(9):1479-1485. 

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surgery will need a method to eliminate or reduce corneal cylinder.  Kessel et. Al., compared the 
two most commonly available options to reduce astigmatism and noted that the most effective way 
to reduce astigmatism is by implanting a toric IOL.2  For toric IOLs to be effective, IOL rotation after 
implantation must be minimal; it has been noted that as little as 1 degree of rotation can result in 
3.3% reduction in the toric lens effectiveness in reducing astigmatism.   
JJSV has developed a new IOL platform designed to minimize rotation to ≤ 5⁰ within the first week 
after implantation. The TECNIS® Toric II 1-Piece lens is an ultraviolet light-absorbing posterior 
chamber intraocular lens (IOL) that compensates for corneal spherical aberrations and corneal 
astigmatism. The benefits of aspheric compensation for corneal spherical aberrations are 
contingent upon full refractive correction of sphere and cylinder. The IOLs incorporate a proprietary 
wavefront-designed toric aspheric optic with a squared posterior optic edge designed to provide a 
360⁰ barrier. The edge of the optic has a frosted design to reduce potential edge glare effects. In 
addition, compared to the TECNIS Toric 1-Piece IOL, the haptics of the TECNIS Toric II 1-Piece 
IOLs have a squared and frosted design. The anteriorly located cylinder axis marks denote the 
meridian with the lowest power and is to be aligned with the steep corneal meridian.  
3. 
CLINICAL HYPOTHESIS 
TECNIS Toric II IOL will demonstrate excellent rotational stability by demonstrating ≤ 5º of axis 
misalignment from the intended IOL axis of orientation in 90% of the eyes at the 1-week 
postoperative visit. 
4. 
STUDY DESIGN 
This is a prospective, multicenter, single-arm, open-label clinical study of the commercially 
available TECNIS Toric II IOL.  The study will be conducted in up to 192 subjects needing unilateral 
or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for 
up to 3-months postoperatively.   
 
5. 
ACRONYMS 
The following acronyms are used throughout this document:   
• ADE:  adverse device effect 
• AK: astigmatic keratotomy 
• BCDVA: best-corrected distance visual acuity 
• BSS: balanced salt solution 
• CRF: case report form 
                                               
2 Kessel L, Andresen J, Tendal B, Erngaard D, Flesner P, Hjortdal J. Toric Intraocular Lenses in the Correction of 
Astigmatism During Cataract Surgery: A Systematic Review and Meta-analysis. Ophthalmology. 2016;123(2):275-
286. 

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• CRI: corneal relaxing incisions 
• D: diopters 
• DFU: directions for use 
• EDC: electronic data capture 
• GCP: good clinical practice 
• HIPAA: health insurance portability and accountability act 
• ICF: informed consent form 
• IOL: intraocular lens 
• IOP: intraocular pressure 
• IRB: institutional review board 
• ISQ: investigator satisfaction questionnaire 
• LASIK: laser-assisted in-situ keratomileusis 
• LASEK: laser epithelial keratomileusis 
• LRI: limbal relaxing incisions 
• OCCI: opposite clear corneal incisions 
• OR: operating room 
• PRK: photorefractive keratectomy 
• PSQ: patient satisfaction questionnaire 
• SAE: serious adverse events 

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• UCDVA: uncorrected distance visual acuity 
• UADE:  unanticipated adverse device effect 
• USADE: unanticipated serious adverse device effect 
6. 
STUDY OBJECTIVES AND ENDPOINTS 
The purpose of this clinical study is to evaluate the rotational stability of the TECNIS® Toric II IOL.  
Primary endpoint is percentage of eyes with ≤ 5º axis misalignment from the intended IOL axis of 
orientation at the 1-week postoperative visit.  
The final 3-month visit will be the key timepoint for visual acuity, manifest refraction and patient 
and investigator reported outcomes questionnaire evaluations.  Other timeframes will be provided 
as supportive analysis.  
6.1 
PRIMARY ENDPOINT 
The primary endpoint for the study is the percentage of eyes with ≤ 5º axis misalignment from the 
intended IOL axis of orientation at the 1-week postoperative visit. Rotational stability of the IOL will 
be evaluated by measuring axis misalignment, which is defined as the absolute difference between 
intended IOL axis of orientation (immediately at the end of the surgery) and follow-up visit(s) as 
measured by a photographic based method. 
6.2 
OTHER ENDPOINTS 
• 
Residual mean manifest cylinder and spherical equivalent for all eyes 
• 
Percentage of eyes that achieve UCDVA of 20/40, 20/32, 20/25 & 20/20  
• 
Percentage of eyes that achieve accuracy of cylinder (to target): 
o within: ± 0.50 D and ± 1.00 D  
• 
Analysis of lens axis misalignment (compared to target) including:  
o Mean absolute and signed value of the misalignment 
o Percentage of eyes with lens axis misalignments ≤ 5º, < 10º, < 20º and >30º  
• 
Medical findings/Lens findings/Complications 
• 
Subject responses on Patient Satisfaction Questionnaire (PSQ)  
NOTE: Should be administered only in subjects who have been implanted with the study 
lens bilaterally 
• 
Investigator responses on Investigator Satisfaction Questionnaire (ISQ) 
• 
Adverse event rates including the rate of IOL repositioning and/or IOL exchange primarily 
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7. 
STUDY PRODUCTS 
7.1 
INTRAOCULAR LENSES  
The TECNIS® Toric II IOL (study lens), Models ZCU150, ZCU225, ZCU300, ZCU375, ZCU450, 
ZCU525, and ZCU600 are posterior chamber, 1-piece, aspheric, hydrophobic acrylic foldable IOLs 
and are to be implanted in the capsular bag following cataract extraction. It is designed to minimize 
the occurrence of large rotations (greater than 10°) following implantation.  
The TECNIS Toric II is a UV light-absorbing posterior chamber lens that compensates for corneal 
spherical aberrations and corneal astigmatism. The benefits of aspheric compensation for corneal 
spherical aberrations are contingent upon full correction of spherical (defocus) and cylindrical 
(astigmatic) refractive error.  
The TECNIS Toric II incorporates an aspheric optic with a squared posterior optic edge designed 
to provide a 360° barrier for reducing the incidence of posterior capsular opacification (PCO). The 
visual benefits of the proprietary wavefront-designed aspheric optic have been clinically assessed 
using the TECNIS Z9000 IOL (under Investigational Device Exemption G960221). As featured in 
the currently marketed TECNIS Toric (ZCT Series) design, the edge of the optic is frosted to reduce 
potential for edge glare effects.  
The TECNIS Toric II IOLs have two sets of four axis orientation marks 180o apart in the outer 
periphery of the anterior optic surface to indicate the meridian of the lowest power (flat meridian).  
These axis orientation marks are for proper alignment of the flat meridian of the IOL with the steep 
meridian of the corneal curvature. 
The ZCU150, ZCU225, ZCU300, ZCU375, ZCU450, ZCU525, and ZCU600 lens models are 
intended for cataract patients with pre-existing corneal astigmatism that, when taking surgically 
induced astigmatism into account, have approximately 0.75 D to 4.75 D of predicted corneal 
astigmatism to be corrected (Table 1). 
TABLE 1: TECNIS® Toric II Models ZCU, IOL Astigmatism Correction Range 
*The corresponding cylinder values at the corneal plane have been calculated based on the 
average pseudophakic eye. 
Table 2 lists the general design characteristics of the TECNIS Toric II IOLs. 
 
Cylinder Powers (D) 
IOL Model 
ZCU150 
ZCU225 
ZCU300 
ZCU375 
ZCU450 
ZCU525 
ZCU600 
IOL Plane 
(Labeled) 
1.50 
2.25 
3.00 
3.75 
4.50 
5.25 
6.00 
Corneal 
Plane* 
1.03 
1.54 
2.06 
2.57 
3.08 
3.60 
4.11 

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Subjects will be enrolled at each site sequentially until the overall study recruitment goals are met 
or the site limit is reached.   
8.1 
INCLUSION CRITERIA  
1. Minimum 22 years of age; 
2. Unilateral or Bilateral cataracts for which cataract extraction and posterior chamber IOL 
implantation have been planned; 
3. Pre-existing corneal astigmatism of one diopter or greater; 
4. Predicted residual refractive cylinder based on toric IOL calculator, considering 
surgically induced astigmatism (SIA) and posterior corneal astigmatism (PCA) must be 
≤0.50 D; 
5. Potential for postoperative BCDVA of 20/30 Snellen or better; 
6. Clear intraocular media other than cataract in each eye; 
7. Availability, willingness and sufficient cognitive awareness to comply with examination 
procedures and study visits; 
8. Signed informed consent form (ICF) and health insurance portability and accountability 
act (HIPAA) authorization; 
9. Ability to understand and respond to a questionnaire in English. 
8.2 
EXCLUSION CRITERIA  
1. Irregular corneal astigmatism; 
2. Any corneal pathology/abnormality other than regular corneal astigmatism or corneal 
instability due to contact lens wear; 
3. Previous corneal or intraocular surgery; 
4. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, 
nystagmus, etc.); 
5. Any pupil abnormalities (non-reactive, fixed, or abnormally shaped pupils); 
6. Dilated pupil size of < 6.0 mm; 
7. Recurrent severe anterior or posterior segment inflammation or uveitis; 
8. Subjects with conditions associated with increased risk of zonular rupture, including 
capsular or zonular abnormalities that may lead to IOL decentration, including 
pseudoexfoliation, trauma, or posterior capsule defects; 
9. Known ocular or systemic disease that, in the opinion of the investigator, may affect 
visual acuity or require surgical intervention during the course of the study, [macular 
degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), 

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uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, 
concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, 
non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.]; 
10. Use of systemic or ocular medications (e.g., Flomax)  that may affect vision including 
prior, current, or anticipated use during the course of the study that may, in the opinion 
of the investigator, confound the outcome or increase the risk to the subject (e.g., poor 
dilation or a lack of adequate iris structure to perform standard cataract surgery); 
11. Patient is pregnant, plans to become pregnant, is lactating or has another condition 
associated with the fluctuation of hormones that could lead to refractive changes; 
12. Concurrent participation or participation within 30 days prior to the preoperative visit in 
any other clinical study; 
13. Planned monovision correction (eye designated for near correction). 
NOTE: Physicians considering enrolling a patient with one or more of the conditions listed under 
the warning or precaution in the final approved labeling of the device should weigh the potential 
risk/benefit ratio before enrollment. 
9. 
INVESTIGATOR SELECTION 
9.1 
INVESTIGATOR QUALIFICATIONS 
JJSV will select ophthalmic surgeons who have completed a residency in ophthalmology (or its 
documented equivalent) and are licensed to practice medicine and perform surgery at his/her 
investigative site. Each site will have one designated principal investigator; some sites may have 
additional implanting sub-investigators/surgeons.   
Investigators will be selected from surgeons who are experienced in small-incision surgery and 
have implanted toric IOLs in cataract patients All sites are required to have adequate staff support 
for reporting and subject follow-up, as well as the necessary instrumentation to conduct study 
testing. 
9.2 
INVESTIGATOR OBLIGATIONS 
Investigators are required to fulfill the following obligations: 
• 
Conduct the study in accordance with the relevant and current protocol and all legal 
requirements for clinical trials including ISO 14155 and Good Clinical Practice (GCP). 
Investigator will only make changes to a protocol after notifying and obtaining approval from 
JJSV and the Institutional Review Board (IRB) except when necessary to protect the safety, 
rights or welfare of subjects. 
• 
Personally conduct and supervise the study. 
• 
Maintain a list of appropriately qualified persons to whom the investigator has delegated 
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• 
Be responsible for protecting the rights, safety and welfare of subjects under the investigator’s 
care. 
• 
Maintain confidentiality as required by HIPAA or similar laws and regulations. 
• 
Shall not obtain written ICF any subject to participate or allow any subject to participate before 
obtaining IRB approval. 
• 
Document in each subject’s case history that informed consent was obtained prior to 
participation in the study. 
• 
Report to JJSV and the reviewing IRB any adverse experiences that occur during the study in 
accordance with applicable laws and regulations. 
• 
Read and understand the information in the DFU for the study. 
• 
Maintain adequate and accurate records in accordance with applicable laws and regulations 
and make available all study documents and subject medical records for inspection by either 
JJSV, duly authorized regulatory agencies (e.g., FDA) and/or the IRB. 
• 
Submit progress reports on the investigation to JJSV and the reviewing IRB at regular intervals, 
but no less often than yearly. 
• 
Ensure the IRB that is responsible for initial and continuing review of the study complies with 
applicable laws and regulations. 
• 
Report all changes in research activity and all unanticipated problems involving risks to patients 
to the IRB and JJSV. 
• 
Provide sufficient accurate financial information to JJSV to allow JJSV to submit complete and 
accurate certification or disclosure statements.  Promptly update this information if any relevant 
changes occur during the investigation or for up to one year following completion of the study. 
• 
Comply with all other obligations of clinical investigators and requirements according to all 
applicable U.S. regulations and all conditions of approval imposed by the reviewing IRB.  
• 
Ensure that all associates, colleagues and employees assisting in the conduct of the study are 
adequately informed about the protocol, the investigational device, their study-related duties 
and functions and agree to fulfill their obligations in meeting the above commitments. 
Investigators shall provide adequate time and resources to conduct and report on the study. The 
Investigator, or delegate, shall notify JJSV of any change in the conduct of the study including 
changes in study personnel assigned to the study project or maintenance of study records, etc.  
9.3 
INVESTIGATOR APPROVAL  
It is the responsibility of the investigator to obtain prospective approval of the study protocol, 
protocol amendments or changes, ICF and other relevant documents (e.g., advertisements) from 
the IRB.  All correspondence with the IRB should be retained in the Investigator Study 

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Files/Notebook.  Copies of IRB submissions and approvals should be forwarded to JJSV.  Study 
sites will obtain IRB approvals and fulfill any other site-specific regulatory requirements.  The 
investigator is required to report to JJSV within five working days any withdrawal of approval by 
the reviewing IRB for his/her participation in the investigation.  
Prior to the start of subject enrollment, the following documents must be signed and returned to 
JJSV: 
• 
Confidentiality Agreement 
• 
Clinical Study Agreement 
• 
Investigator Agreement/Protocol Signature page 
• 
Financial Disclosure form 
• 
Signed and dated copy of investigator’s current curriculum vitae 
• 
Copy of the investigator’s current medical license  
By signing the study documents, the investigator agrees to conduct this study according to the 
obligations above and all other applicable regulatory and legal requirements. 
10. 
EXPERIMENTAL PLAN 
10.1 
OVERVIEW 
This study will be conducted in accordance with the Declaration of Helsinki, ISO 14155:2011 and 
all other applicable laws and regulations. The study will not begin until IRB approval has been 
obtained. 
This study will be a prospective, multicenter, single-arm, open-label clinical investigation 
conducted at up to 8 sites.  Up to 192 subjects (116- bilateral and 76- unilateral) will be enrolled to 
achieve approximately 200 eyes available for analysis at 1-week with a target of 75% of the eyes 
coming from bilateral subjects and 25% of the eyes coming from unilateral subjects.  After ICF is 
obtained and confirmation that all eligibility criteria are met, the eyes may be treated with the study 
lens.   
The investigator will choose which eye to operate on first for each subject at his/her discretion and 
standard clinical practice (e.g., the eye with the worse cataract, poorer best-corrected distance 
vision and/or more severe optical/visual complaints).  All bilateral subjects are intended to have 
bilateral cataract surgery with the second-eye surgery occurring no more than 30 days after the 
first eye surgery.  All subjects will be examined through 3 months postoperatively according to the 
visit schedule described in Section 10.2, Visit Schedule. 
To maintain consistency, it is recommended that a single individual (study technician or coordinator 
designated by the investigator) conduct all postoperative study-related vision testing, although a 
back-up person should also be designated and trained.   

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Key preoperative data include ocular health and history, pupil measurement, visual acuities, 
keratometry, intraocular pressure (IOP), biomicroscopic slit lamp findings, fundus exam findings, 
and biometry.   
The operative visit will include standard procedures for cataract surgery and IOL implantation as 
well as photographic image of the IOL position, complications and adverse event assessment.   
Key postoperative data include photographic image of the IOL position, manifest refraction, 
UCDVA, BCDVA, slit lamp findings, non-directed visual symptoms, PSQ, ISQ and adverse events. 
PSQ should be administered only to subjects that undergo bilateral implantation with study lenses. 
A chart summary of all examination procedures required at each study visit is provided in 
Appendix A.  If needed, specific equipment necessary to perform the required procedures may 
be supplied for the duration of the study (Appendix B). 
10.2 
VISIT SCHEDULE 
The study visit schedule for all study subjects is outlined in Table 2.   
All subjects are intended to have unilateral or bilateral cataract surgery with the study lens. In 
bilateral subjects the second eye surgery should occur no more than 30 days after the first eye 
surgery.  For both unilateral and bilateral subjects, after each surgery, the operative eye should be 
examined at 1 day (1-2 days), 1 week (5-14 days) and 3-months (60-120 days) postoperative.  For 
bilateral subjects, based on the date of the second-eye surgery, both eyes should be evaluated at 
the same 3-month postoperative visit. Unscheduled visits may be conducted as necessary at the 
discretion of the investigator for medically-indicated follow-up.   

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As the ICF is signed at the beginning of the preoperative study exam, some subjects may not 
qualify after study-specific testing is performed.  Subjects will be considered screen-failures if they 
do not qualify, or if they qualify but decide not to participate further in the study, or if they decide 
not to proceed with surgery.  These subjects will be exited from the study.   
Preoperative testing to be performed for each enrolled eye includes the following: 
POTENTIAL DISTANCE VISUAL ACUITY   
The subject must be capable of achieving Snellen 20/30 or better best-corrected distance vision 
in each eye after cataract extraction and IOL implantation.  The surgeon may use his/her judgment, 
the Potential Acuity Meter (PAM), or other methods (e.g., pinhole, laser interferometer, etc.) to 
estimate the subject’s potential postoperative acuity. 
BEST-CORRECTED VISUAL ACUITY AND MANIFEST REFRACTION 
The standard manifest refraction should be performed and monocular BCDVA should be recorded 
using a standard Snellen chart or equivalent.  
KERATOMETRY  
Preoperative corneal astigmatism should be determined by biometric keratometry readings. The 
same method used preoperatively must also be used at the postoperative visits. 
CONTACT LENS WEAR AND CORNEAL STABILITY 
The surgeon should follow their routine procedures to establish keratometric corneal stability in 
contact lens wearers before surgery.  
NOTE:  PMMA contact lenses are not to be worn for at least 6 months; rigid gas-permeable contact 
lenses are not to be worn for at least 1 month; and extended-wear or daily-wear soft contact lenses 
are not to be worn for at least 1 week prior to the preoperative visit.   
IOL POWER AND TARGETED REFRACTION  
Keratometry, axial length and anterior chamber depth (ACD) must be measured to determine the 
appropriate lens power for implantation.  Optical biometry methods (i.e., IOLMaster® or 
LENSTAR®) are preferred; however, surgeons should use the biometry method based on their 
experience and medical judgement. 
The spherical equivalent lens power, as determined by the investigator’s standard biometry 
methods, should be calculated to achieve emmetropia (± 0.50 D) at distance for all eyes.  
Intentional overcorrection or under-correction (i.e., outside ± 0.50 D) should NOT be planned for 
either eye; however, surgeons may adjust the targeted refraction as necessary to achieve 
emmetropia based on their surgeon factor, study subject experience and/or subject first-eye 
outcomes.      
NOTE: Surgeon may choose to use 119.3 or personalized A-constant for the TECNIS® Toric ZCU 
lens.  

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ADDITIONAL PREOPERATIVE INFORMATION COLLECTED SHOULD INCLUDE: 
• 
Informed consent  
• 
Subject demographic information  
• 
Planned surgery dates for each enrolled eye 
• 
Ocular history, including presence of ocular pathology for each enrolled eye  
• 
Dilated pupil size (measured by standard practice at the study site). 
• 
Any medical findings from a slit lamp exam, dilated fundus exam, intraocular pressure or other 
assessment. 
• 
Ocular and systemic medications 
10.4 
STUDY LENS SUPPLY 
The principal investigator will implant lenses from their commercial TECNIS Toric II inventory. 
10.5 
SELECTION OF THE IOL 
In order to facilitate IOL selection and axis placement, JJSV provides a web-based proprietary tool, 
the TECNIS Toric Calculator (www.TecnisToricCalc.com) for the surgeon. Preoperative 
keratometry, biometry data, incision location, spherical equivalent IOL power, and the surgeon’s 
estimated surgically induced corneal astigmatism are used as inputs for the TECNIS Toric 
Calculator. These inputs are used to determine the axis of placement in the eye and the predicted 
residual refractive astigmatism for TECNIS Toric II 1-Piece IOL models.  
NOTE: The TECNIS Toric Calculator also provides an option for including the Posterior Corneal 
Astigmatism (PCA). The predetermined value for posterior corneal astigmatism must be included 
in the calculation by checking the box labeled “Include Posterior Corneal Astigmatism (PCA)”.  
Surgeons can use their preferred Toric Calculator for determination of lens axis placement. 
10.6 
OPERATIVE PROCEDURES  
Surgical procedures should be in accordance with your routine practice and in accordance with 
the labeling. The surgeons should follow the procedures as described in the DFU for appropriate 
alignment of the IOL axis.  
NOTE: No additional refractive procedures are to be performed during the operative procedure or 
throughout the postoperative study period (e.g., LRI, OCCI, CRI, AK, PRK, LASIK or LASEK). 
Additional procedures such as MIGS (minimally invasive glaucoma surgery) may be allowed 
following consultation with the medical monitor.  
Optiwave Refractive Analysis (ORA) can be used as a part of routine cataract surgery to improve 
accuracy of the correction.  If ORA is used it will be documented in the Operative case report form. 
REFERENCE AXIS 

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Prior to surgery the operative eye should be marked per the surgeon’s routine standard of care 
method.  
Operative case report forms should include the following information: 
INCISION TYPE AND SIZE 
The incision may be clear corneal, limbal or scleral tunnel at the discretion of the investigator. 
Lenses should be inserted per the investigator’s standard technique when using the JJSV-qualified 
implantation system. 
CAPSULORHEXIS SIZE AND METHOD  
The anterior capsulotomy should be made per investigator’s standard technique.  The anterior 
capsulotomy method may be manual (rhexis) or laser-assisted.  
CRYSTALLINE LENS REMOVAL 
Crystalline lens removal may occur using laser-assisted fragmentation combined with 
phacoemulsification/aspiration or using only phacoemulsification/aspiration.  
BALANCED SALT SOLUTION (BSS) STERILE IRRIGATING SOLUTION 
BSS solution should be used as is customary for each investigator and recorded on the case 
report form. 
VISCOELASTIC   
Viscoelastic materials should be used as is customary for each investigator and recorded on the 
case report form (CRF). 
IMPLANT INSTRUMENTATION USED   
Lenses should be folded for implantation and inserted into the capsular bag using either the 
UNFOLDER 
Platinum-1 
Series 
Implantation 
System 
(DK7796 
handpiece 
with 
the 
Platinum-1 Series cartridge, Model 1MTEC30), the UNFOLDER® EMERALD-AR Series 
Implantation System (with the 1CART30 Cartridge), the ONE SERIES Ultra Insertion System (the 
1VPR30 Cartridge and the DK7786 or DK7791 inserters), or any other Johnson & Johnson 
Surgical Vision, Inc.-qualified insertion system.   
NOTE: Use of capsular tension ring is not allowed. 
SURGICAL COMPLICATIONS   
Should a surgical complication occur, implantation of a study lens will be at the investigator’s 
discretion.  In the event of capsular bag or zonular rupture, the lens should not be implanted.  
Additionally, the lens is not to be implanted in the sulcus.  In this case, the investigator may implant 
his/her choice of a back-up IOL.  The subject should be exited from the study if a non-study lens 
is implanted as a result of a surgical complication during the first eye implantation; however, the 
eye will be followed until resolution of the complication prior to exiting the subject. Should a surgical 
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the subject will not be exited from the study; the first eye will continue to be followed per-protocol, 
although data may be analyzed separately, and the second eye will be followed for safety until 
resolution of the complication. 
MEDICATIONS   
Preoperative, operative and intraoperative medications should be used as is customary for each 
investigator and recorded in the source document for each subject, as appropriate.  At the 
operative and postoperative visits, only medications required for treatment of an SAE will be 
recorded on the CRFs.  
TYPE OF CLOSURE   
Wound closure is left to the surgeon’s discretion and will be recorded on the CRF. 
BASELINE PHOTOGRAPH OF THE IOL POSITION 
At the end of each case (regardless of whether repositioning was required), a minimum of 3 high-
quality photographs should be taken through the surgical microscope showing the lens in its final 
position. Care should be taken to ensure clear visibility in the photo of both the scleral vessels and 
the lens axis marks as this will be the baseline image for all future rotation measurements. 
Appendix C provides detailed instructions for capturing photographs through the surgical 
microscope. If video capabilities are available, the surgeon should capture the entire surgery 
through the surgical microscope on video. If at the end of surgery, a high-quality image of the eye 
cannot be obtained for any reason, then a slit lamp photograph should be taken following surgery 
as a back-up. 
ADDITIONAL OPERATIVE INFORMATION COLLECTED SHOULD INCLUDE: 
• 
Date of surgery 
• 
Operative eye 
• 
Lens power and serial number 
• 
Intended spherical equivalent 
• 
Intended cylinder 
• 
Capsular bag polishing  
• 
Lens placement 
• 
Surgical complications or other surgical procedures 
• 
Difficulty of lens implantation 
• 
Product complaints 
• 
Serious and/or device-related adverse events 
• 
Confirmation that surgical photos have been taken/uploaded 

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10.7 
POSTOPERATIVE PROCEDURES  
Postoperatively, subjects will be examined according to the schedule in Section 10.2, Visit 
Schedule.   
To maintain consistency, it is recommended that only the investigator/ sub-investigator or other 
designated and trained clinician perform the slit lamp exams and slit lamp photographs, although 
a back-up person should also be designated and trained  Also, it is recommended that a single 
individual (study technician or coordinator designated by the investigator) conduct all postoperative 
study-related vision testing, although a back-up person should also be designated and trained.  
The postoperative CRF will be used to collect the following postoperative information, although not 
all data are required at every visit: 
UNCORRECTED DISTANCE VISUAL ACUITY TESTING 
Monocular and binocular visual acuities will be measured using the ETDRS (Early Treatment 
Diabetic Retinopathy Study) chart presented on a self-calibrating monitor in the M&S system at 4 
meters (13 feet) under photopic (85-110 cd/m2) conditions.  Instructions for using the M&S System 
are detailed in Appendix D, and for distance visual acuity in Appendix E. Monocular UCDVA 
should be measured at 1-day, 1-week and 3-months study visits. Binocular UCDVA should be 
measured at the 3-month study visit only in subjects bilaterally implanted with the study lens. 
NOTE: To adjust 4.0-meter to optical infinity, +0.25 D lens must be placed in the trial frame for 
each eye before measuring UCDVA.  
MANIFEST REFRACTION  
Postoperative manifest refractions are to be performed using the M&S System at a distance of 4.0 
meters.  Manifest refraction is to performed using the Maximum Plus refraction method as detailed 
in Appendix F.  Also refer to Appendix G, Refraction Adjustments. 
BEST-CORRECTED DISTANCE VISUAL ACUITY  
Monocular visual acuities will be measured using the M&S System at 4 meters (13 feet) under 
photopic (80-110 cd/m2) conditions. Instructions for using the M&S System are detailed in 
Appendix D, and for distance visual acuity in Appendix E. 
KERATOMETRY  
Corneal astigmatism should be determined by biometry keratometric readings. The same method 
used preoperatively must also be used at the postoperative visit (1-week and 3-month). 
BIOMICROSCOPIC SLIT LAMP EXAM   
A biomicroscopic slit lamp exam must be performed at each postoperative visit to determine the 
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Findings of aqueous cells and flare, corneal edema, posterior capsule striae (wrinkles), posterior 
capsular opacification, and IOL glistenings are to be rated using standardized grading scales of 0 
to +4 (0 = none, +4 = severe) during the slit lamp biomicroscopy. The specific grading scales are 
provided in Appendix H.   
BIOMICROSCOPIC SLIT LAMP PHOTOGRAPHS AND LENS AXIS ORIENTATION 
Study subjects are to have their pupils dilated to approximately 6 mm or more at each 
postoperative visit in order to take slit lamp photographs that capture limbal vessels and iris detail 
with precise focus, while also capturing the lens fiducial marks with reasonable focus (the cameras 
focal plane should be anterior to the IOL fiducials; see Appendix I).  
The lens orientation should also be measured by the investigator, or other study personnel, by 
rotating the slit lamp beam to match the IOL axis orientation and reading the axis to the nearest 
degree from the scale (see Appendix J). 
ND:YAG CAPSULOTOMY 
If a Nd:YAG capsulotomy is necessary, it is recommended that the procedure be performed at 
least 1 week prior to a study exam; this is particularly important for the 3-month study visit, as this 
is the key study exam for evaluation of safety and effectiveness.  
FUNDUS EXAM 
A fundus exam is to be performed at the 3-month visit to evaluate retinal status and fundus 
visualization.  Examinations may be done dilated with ophthalmoscopy.  
INTRAOCULAR PRESSURE  
Intraocular pressure (IOP) is to be measured using the investigator’s usual method.  It is 
recommended that the same method be used for all study subjects at the site for the duration of 
the study. 
OCULAR SYMPTOMS (NON-DIRECTED; SPONTANEOUS) 
Subjective ocular symptoms are to be assessed at each postoperative visit by asking “Are you 
having any difficulties with your eyes/vision?”  Subjects should not be prompted for specific 
responses; however, if subjects report any issues, they should be recorded, and the level of 
severity determined (mild, moderate or severe) as appropriate. 
MEDICATIONS   
Postoperative ocular medications should be used as is customary for each investigator and 
recorded in the source document for each subject, as appropriate. Only medications required for 
treatment of a serious adverse event (SAE) will be recorded on the case report forms. 
PATIENT SATISFACTION QUESTIONNAIRE (PSQ) 

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The 2-item questionnaire will be administered at the 3-month visit to collect information regarding 
spectacle usage, and subject satisfaction (Appendix K). PSQ should be administered only to 
subjects that undergo bilateral implantation with study lenses.   
INVESTIGATOR SATISFACTION QUESTIONNAIRE (ISQ) 
This 3-item questionnaire is self-administered and should be completed by the PI or sub-PI 
examining the subject. The purpose of this questionnaire is to collect investigator satisfaction with 
the clinical outcomes (e.g., rotational stability, uncorrected distance visual acuity) of the eyes 
implanted with the study lens. At the 1-week and 3-month visits, investigator feedback from the 3-
item ISQ will be collected for each implanted eye (Appendix L).  
ADVERSE EVENTS 
Subjects should be assessed at each visit for occurrence of and/or change in status of any adverse 
events, particularly serious and/or device-related adverse events.  See Section 11.0 Adverse 
Events and Appendix M for further information.  
Secondary Surgical Interventions 
Secondary surgical interventions due to refractive error and/or medical complications are serious 
adverse events. Secondary surgical interventions have become the standard of care in some 
cases and are considered to be in the subject’s best interest. The clinical protocol will allow for 
secondary surgical interventions in the following categories: 
• 
IOL repositioning due to a significant axis misalignment resulting in a visual outcome that 
is unsatisfactory, providing the axis misalignment is rotationally correctable.  
• 
IOL exchange due to incorrect spherical power resulting in a significant decrease in 
uncorrected visual acuity. 
• 
IOL exchange due to surgical or postoperative medical complications or adverse events. 
If IOL repositioning procedure is required, the investigator should collect dilated slit lamp 
photograph showing IOL position prior to reposition.  
NOTE: If a toric IOL is repositioned, the subject will continue to be followed through study 
completion for safety. If a toric IOL is exchanged for a non-toric IOL, the subject should be followed 
until resolution of the serious adverse event/adverse device effect. 
10.8 
EXIT OF SUBJECTS 
An Exit CRF will be completed for each subject that completes the study or exits the study before 
completing all scheduled visits.   
It is the responsibility of the investigator to provide complete follow-up data to JJSV for each 
subject, and every attempt should be made to gather that complete follow-up data for all subjects 
enrolled, as missing data can have a negative effect on the study results. Patients who would be 

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traveling, relocating or otherwise unavailable for postoperative follow-up visits should not be 
enrolled in this clinical study. 
A subject will be considered a "screen failure" if he/she does not meet the eligibility criteria, consent 
is withdrawn prior to surgery, implantation in the first eye is aborted due to a surgical complication, 
or the subject dies prior to first-eye treatment.  
Should a surgical complication occur during the second-eye surgery and result in implantation of 
a non-study lens, the subject will not be exited from the study; the first eye will continue to be 
followed per-protocol. 
Subjects will be "discontinued" from the study if the subject does not undergo surgery; or if both 
study lenses are removed; or if the subject dies. 
If a subject receives at least one study lens, he/she is to be followed according to the schedule in 
Table 2 (Section 10.2) for visit windows.   
Subjects will be considered “lost-to-follow-up” from the study only if irretrievably lost for 
unavoidable reasons such as: subject moved/unable to locate, subject ill/unable to travel, subject 
uncooperative/refuses further study participation.  In the event of subject relocation, effort must be 
made by the investigator to secure follow-up information (i.e., slit lamp findings and general visual 
acuity, etc.) from the subject’s new physician.   
If a subject is exited early from the study, the investigator must indicate the reason for study exit 
on the CRF.  In the event of a lens removal or other serious adverse event, the subject may be 
exited from the study; however, effort must be made by the investigator to follow the subject until 
resolution of the adverse event before exiting the subject from the study. 
All study subjects are to be instructed to undergo regular eye examinations at least yearly and also 
to return to their doctor if any eye complications are experienced.   
10.9 
UNSCHEDULED VISITS  
During the study period, if a non-protocol-required visit is done for the purpose of medically-
indicated follow-up for a study eye, data from this visit should be reported using the Unscheduled 
Visit CRF. The need for unscheduled visits is at the investigator’s discretion.  Specific examinations 
to be performed at unscheduled visits are also at the discretion of the investigator (based on the 
reason for the unscheduled visit) and data are to be recorded in the appropriate section of the 
CRF. 
Data to be collected may include: 
• 
Manifest refraction (using standard Snellen Chart)  
• 
Uncorrected and best-corrected Snellen distance visual acuity  
• 
Intraocular pressure 
• 
Slit lamp examination for medical and/or lens findings  

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• 
Slit lamp photographs of IOL position 
• 
Dilated or undilated fundus exam 
• 
Ocular symptoms 
• 
Adverse events 
• 
Medications 
If in the opinion of the investigator, IOL misalignment is suspected to be the cause of subjects’ 
visual complaint at an unscheduled visit, the investigator should collect UCDVA, manifest 
refraction, BCDVA, Keratometry, non-directed visual symptoms, dilated slit lamp photographs 
(Appendix I) and lens axis orientation measurement (Appendix J). 
NOTE: In the opinion of the investigator, if the estimated lens axis orientation remains unchanged 
since the last study visit, slit lamp photographs need not be repeated. 
Conditions found postoperatively, but previously documented at the preoperative visit, do not 
trigger an unscheduled visit report.  However, if the severity of the condition increases from the 
preoperative visit, an Unscheduled Visit CRF is needed. 
10.10 PROTOCOL DEVIATIONS  
Any departure from the protocol procedures represents a protocol deviation.  Protocol deviations 
may be subject-based (e.g., inclusion/exclusion criteria, informed consent deviation, etc.) or 
procedural-based (e.g., out-of-interval visits, non-compliance with testing procedures, etc.).  All 
protocol deviations will be documented in the Clinical Trial Management System.  Any deviation 
made to protect the life or physical well-being of a subject in an emergency must be reported to 
JJSV within 5 working days.  Protocol deviations will be monitored by the Sponsor, and if the non-
compliance is persistent or egregious, Sponsor may take action, including but not limited to 
termination of the investigator’s participation in the study.  The investigator is also responsible for 
informing the reviewing IRB of instances of protocol non-compliance in accordance with the IRB 
requirements. 
11. 
ADVERSE EVENTS AND PRODUCT COMPLAINTS  
11.1 
ADVERSE EVENT DEFINITIONS 
Adverse Event (AE) 
An adverse event is defined (per ISO 14155) as any untoward medical occurrence, unintended 
disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, 
users or other persons, whether related to the study device.   
Serious Adverse Event (SAE) 
An adverse event is considered serious (per ISO 14155) if it is an untoward occurrence which may 
or may not be related to use of the study device that 

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• 
is sight- or life-threatening,  
• 
results in death,  
• 
requires inpatient hospitalization or prolongation of hospitalization (a planned 
hospitalization for a pre-existing condition without a serious deterioration in health is not 
considered a serious adverse event), 
• 
results in permanent impairment of a body structure or body function,  
• 
necessitates medical or surgical intervention to prevent permanent impairment to a body 
structure or function, or 
• 
results in fetal distress, fetal death or a congenital abnormality or birth defect 
Device-Related Adverse Event/Adverse Device Effect (ADE) 
A device-related adverse event is defined as any adverse event that is believed to be definitely, 
probably, possibly or unlikely to be related to the study device (following the guidelines in Section 
11.4, Causal Relationship).  A device-related event is also considered an adverse device effect 
(ADE; following ISO 14155) resulting from the use of the study device that may result from user 
error, insufficiencies or inadequacies in the instructions for use, deployment, implantation, 
installation, operation of any malfunction of the device.   
Anticipated Study-Specific Serious Adverse Events 
The following is a list including, but not limited to, ocular serious adverse events (SAE) that are 
anticipated and must be reported to JJSV for this study.  Any events that are unlikely but 
anticipated (i.e., endophthalmitis) will be reported to the FDA and other appropriate regulatory 
agencies.  Adverse event definitions in accordance with the American Academy of Ophthalmology 
Task Force Consensus Statement are included in Appendix N. 
• 
Endophthalmitis/intraocular infection 
• 
Hypopyon 
• 
Hyphema 
• 
IOL dislocation 
• 
Cystoid macular edema 
• 
Pupillary block 
• 
Retinal detachment/tear 
• 
Corneal edema  
• 
Chronic anterior uveitis/iritis   
• 
Raised IOP that persists (i.e., is present at the last study visit) 

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• 
Toxic anterior segment syndrome 
• 
Visual symptoms requiring secondary surgical intervention (e.g., lens removal) 
• 
Tilt and decentration requiring secondary surgical intervention (e.g., repositioning) 
• 
Residual refractive error resulting in a secondary surgical intervention 
• 
Retained lens material resulting in secondary surgical intervention 
NOTE 1:  Wound “burps” during the first week postoperatively, suture removal, planned 
blepharoplasty, and Nd:YAG capsulotomy (for PCO) are not considered adverse events for this 
study. 
NOTE 2: Corneal edema, and chronic anterior uveitis/iritis will be considered serious according to 
the guidelines listed in Appendix N (i.e., BCDVA of 20/40 or worse at 1 month or later; and Grade 
1+ uveitis/iritis persists for greater than 3 months after surgery).  Raised IOP, according to the 
guidelines listed in Appendix N will be considered serious if present at the last study visit (60-120 
days after second eye).  
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse Device Effect 
(USADE) 
Any UADE (21CFR 812.3(s)) or USADE (ISO 14155) is defined as any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, a device, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan (i.e., this protocol), application (including a supplementary plan 
or application), or risk assessment, or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects.   
11.2 
PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION 
A product complaint/device deficiency is defined (21 CFR 820.3(b) and ISO 14155) as any alleged 
deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance 
of a device. This may include malfunctions, use error, and inadequacies in labeling.  Product 
complaints can pertain to any marketed JJSV device being used in the study.  The investigator is 
to assess whether the deficiency could have led to a serious adverse event without suitable action 
or intervention or under less fortunate circumstances. 
11.3 
ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS 
All adverse events and any complaint encountered using any JJSV product, regardless of severity 
and whether attributed to the study device(s), are to be reported to JJSV and recorded on the case 
report form corresponding to the visit during which awareness of the event occurred.  Adverse 
events are also to be reported to the reviewing IRB as per the IRB’s reporting requirements.  If 
required, adverse events will be reported to the appropriate regulatory agencies (e.g., FDA) 
according to all applicable laws and regulations.   

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Reporting of adverse events shall follow the US Code of Federal Regulations (21CFR 812) for 
sites in the USA. Specific instructions on notification procedures to JJSV are included in Appendix 
M. General guidelines are provided below: 
Adverse Event Reporting 
An adverse event that is not serious or device-related is to be reported to JJSV in a timely manner.  
Notification of non-serious and non-device related adverse events will occur by recording events 
on the CRF when noted.  Such adverse events are also to be reported to the reviewing IRB per 
their reporting requirements.  
Complaints/Device Deficiency Reporting  
A general product complaint or device deficiency is to be reported to JJSV in a timely manner.  
Notification of complaints/device deficiencies will occur by recording complaints on the CRF at the 
visit the complaint occurs (e.g., operative visit) and/or by a phone call/email to JJSV.   
Any device deficiency that could have led to a serious adverse event without suitable action or 
intervention, or under less fortunate circumstances, must be reported to the sponsor immediately 
(no later than 24 hours after detection). Device deficiencies that could have led to a serious 
adverse event should also be reported to the investigator’s IRB per their reporting requirements. 
Serious and/or Device-Related Adverse Event Reporting 
SAEs and/or ADEs are to be documented using the Serious Adverse Event/Adverse Device Effect 
(SAE/ADE) CRF.  In the event of an SAE, JJSV must be notified immediately (no later than 48 
hours after detection).  Any SAE/ADE is to be reported to JJSV by phone, email and/or by 
submitting the completed SAE/ADE CRF.  Any SAE or device-related AE should also be reported 
to the investigator’s IRB per their reporting requirements. 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse Device Effect 
(USADE) Reporting 
If during the study, a serious adverse event occurs that may reasonably be regarded as device-
related and was not previously expected in nature, severity, or degree of incidence, the investigator 
is to report the UADE/USADE to JJSV within 48 hours, and to the investigator’s IRB as soon as 
possible (and no later than 10 working days after learning of the event for sites in the USA as 
required by 21CFR812). 
11.4 
CAUSAL RELATIONSHIP  
The investigator should always be alert to adverse events that may be related to the study device 
or the use of the study device (i.e., the procedure specific to the initial application of the device).  
An attempt should be made in every case to determine the causality of the event.  The following 
definitions are to be used as guidelines in determining the relationship between the event and the 
study device and/or use of the device.   

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Definitely related: 
If the event is associated with the device and/or the use of the device 
beyond a reasonable doubt, a causal relationship exists between the 
adverse event and the device and/or the use of the study device. 
Probably related:   
There is a reasonable possibility of a causal relationship between the 
adverse event and the device and/or the use of the study device and/or 
the adverse event cannot be reasonably explained by another cause. 
Possibly related:   
The adverse event has not been determined to be related to the device or 
the use of the device, but no other cause has been identified and the 
device and/or the use of the study device cannot be ruled out as a possible 
cause. 
Unlikely to be related: The possibility of a potential causal relationship between adverse event 
and the device and/or the use of the device could exist, but the adverse 
event can be reasonably explained by another cause. 
Not related: 
There is no possibility of a causal relationship between the adverse event 
and the device and/or the use of the study device and/or the adverse event 
can be attributed to another cause. 
If an adverse event is believed to be definitely, probably or possibly related to the study device 
and/or the use of the device, the event will be considered related to the study device and/or the 
use of the device.   
11.5 
ADVERSE EVENT FOLLOW-UP 
For every adverse event, appropriate measures should be undertaken to treat and/or monitor the 
subject until resolution occurs.  The subject's files are to include all pertinent medical data relating 
to the event including the subject’s medical records, medical reports and/or judgments from 
colleagues or outside specialists who assisted in the treatment and follow-up of the subject.  The 
investigator should keep JJSV closely informed as to the outcome of serious and/or device-related 
adverse events, thereby allowing JJSV to comply with the appropriate regulatory reporting 
requirements.  An SAE/ADE CRF should be completed each time the subject returns to the 
investigator or other specialist(s) for follow-up of a serious and/or device-related adverse event 
until resolution of the event.  Any subject who is to be exited from the study due to a serious and/or 
device-related adverse event should be followed until the outcome is determined prior to being 
exited from the study. 
12. 
PROTOCOL CHANGES/AMENDMENTS  
If the investigator wishes to modify any procedure and/or the design of the study, he or she must 
contact and obtain consent from JJSV regarding the proposed changes prior to implementation.  
Any modifications (including additional data collection) require approval by the governing IRBs 
prior to implementation.   

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13. 
ETHICS REVIEW AND PATIENT WELFARE 
13.1 
INSTITUTIONAL REVIEW BOARD (IRB) 
It is the responsibility of the investigator to obtain prospective approval of the study protocol, 
protocol amendments or changes, ICF and other relevant documents (e.g., advertisements) from 
the IRB.  All correspondence with the IRB should be retained in the Investigator Study 
Files/Notebook.  Copies of IRB submissions and approvals should be forwarded to JJSV. 
The investigator is responsible for notifying the IRB of reportable adverse events as well as any 
other circumstance in which additional procedures outside the protocol were conducted to 
eliminate apparent hazards to subjects. 
13.2 
INFORMED CONSENT 
The current version of the IRB-approved study ICF must be signed by each study subject prior to 
any study-specific examinations being performed.  The IRB-approved ICF is to be signed and 
dated by the subject as well as by the person who conducted the informed consent discussion.  
The signed ICF will be maintained by the investigator as a permanent part of the subject’s medical 
records.  A copy of the signed and dated form is to be provided to the subject.  The investigator 
will provide JJSV written acknowledgement on the preoperative case report form that a signed 
agreement of informed consent has been obtained and is in the investigator’s possession for each 
subject.  As required by 21CFR 812 Part G, the site shall document in the source documents that 
informed consent was obtained prior to participation in the study for each subject enrolled. 
NOTE:  The informed consent process also includes obtaining the subject’s signature on an 
Authorization for Use/Disclosure of Health Information for Research Form or equivalent 
documentation necessary to comply with applicable privacy laws pertaining to medical treatment 
in the governing countries.   
NOTE:  The sponsor will secure appropriate insurance for study subjects prior to study start. 
14. 
DOCUMENTATION 
14.1 
SOURCE DOCUMENTS 
Source documents must be kept for all study subjects.  Source documents may include a subject’s 
medical records, hospital charts, clinic charts, the investigator’s subject study files, as well as 
results of any diagnostic tests or procedures such as topographies or laboratory tests with 
photographs or instrument printouts. 
Each site is expected to adhere to the clinic’s own standard documentation requirements for 
medical charts/clinic notes.  For the purposes of this clinical study, the medical charts/clinic notes 
must also include, at a minimum, the following data that will be considered source data and will be 
reviewed by the Sponsor: 

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• 
Subject’s name and study identification number 
• 
Subject’s contact information 
• 
Study protocol number and the Sponsor name (JJSV) 
• 
A statement that informed consent was obtained prior to participation in the study (including 
the date)  
• 
Evidence of subject eligibility 
• 
Dates of all subject visits and surgeries throughout the duration of the study 
• 
Implant serial number identification  
• 
Concurrent medications 
• 
Corrected and uncorrected distance visual acuity 
• 
Manifest refraction 
• 
Occurrence and status of any operative complications, postoperative medical or lens findings 
and adverse events 
• 
Occurrence and status of any subject complaints, e.g., ocular/visual symptoms 
• 
The date the subject exited the study, and a notation as to whether the subject completed the 
study or reason for early exit. 
14.2 
SUBJECT CONFIDENTIALITY 
Subjects will be assigned a site/subject number to maintain subject confidentiality.  Subject names 
may possibly be disclosed to JJSV or regulatory agencies during inspection of medical records 
related to the study, but reasonable precautions will be taken to maintain confidentiality of personal 
information to the extent permitted by applicable laws and regulations. 
14.3 
CASE REPORT FORM COMPLETION 
This study will use an electronic data capture system.  All study staff responsible for entering data 
into the system must complete certification prior to using the system.  The investigator is 
responsible for ensuring that data are properly recorded on each subject’s case report forms and 
related documents.  Prior to database lock, the investigator will verify completeness and accuracy 
of data submitted to the Sponsor.  
14.4 
STUDY SUMMARY 
A final investigator’s summary (study close-out) will be provided to the reviewing IRB after 
termination or the completion of the study or the investigator’s part of the study, as directed by the 
Sponsor.  

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15. 
MONITORING  
The Sponsor will perform three types of monitoring to ensure compliance with regulations: data 
monitoring, administrative monitoring, and safety monitoring. 
15.1 
DATA MONITORING 
In order to ensure a well-controlled clinical trial, the Sponsor will follow specific data monitoring 
procedures, routinely generate reports and periodically review safety and effectiveness data.  To 
avoid bias, any analyses generated prior to site closures will not be disseminated to any of the 
investigative sites. 
An electronic data capture system (EDC) will be used to transmit case report forms from the 
investigative site to the Sponsor.  Requests for data clarification will be handled through this same 
system.   
To minimize data omissions and inconsistencies on clinical reports and to ensure that data are 
accurately transcribed to computer data files, the Sponsor will follow internal data processing 
procedures that include automated and manual quality control checks to identify any data 
discrepancies.  Any such items will be resolved and documented as needed in EDC. 
Prevention of Missing Data 
Methods used to safeguard against missing data that can have deleterious effects on the study 
integrity and reliability of its outcomes will include training study staff with WebEx/Skype, 
centralized and/or on-site programs.  In addition, subjects will be encouraged at the time of 
informed consent to avoid missing study visits, as missing data may affect the study reliability and 
diminish the scientific value of their contribution to the study. 
15.2 
ADMINISTRATIVE MONITORING 
Administrative monitoring procedures will ensure that study devices, subjects, and forms can be 
traced and will allow monitoring of investigator progress and compliance.  Accountability and 
traceability of study devices will be monitored by trained Sponsor personnel. 
Site Monitoring Plan 
Prior to performing any study implants, the requirements of the study and reporting mechanisms 
will be explained to each investigator either personally at the investigative site or at a formal study 
investigator meeting.  When necessary, a pre-study site qualification visit may be performed to 
assess the adequacy of the site to perform the study for sites that have not previously worked with 
the Sponsor or have undergone significant changes or have not been visited in the past year.  An 
initial site visit will be conducted prior to the first implant for all sites.  
Throughout the duration of the study, site visits to monitor compliance to this protocol will be made 
at each investigative site.  During interim site monitoring visits, the Sponsor will review informed 
consent documents and subject eligibility, and the data on study case report forms will be verified 
against subject charts and other source documents to ensure complete and accurate reporting.  

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The subject files will also be reviewed to assure that all adverse events and any issues 
encountered with JJSV products have been reported in a timely fashion.  
The Sponsor will also review source documents to verify that all required items have been 
documented in the subject medical charts.  Refer to Section 14.1, Source Documents, for a list of 
items that are required for source documentation.  In addition to subject files, study logs will be 
checked to ensure compliance with study procedures.   
Additional training on study-specific procedures may also be conducted during monitoring visits.   
Upon study completion, a final close-out site visit will be made to each site to monitor the last of 
the subject data records and finalize any outstanding study issues.  
A separate Study Monitoring Plan will be established prior to study start that will define the type 
and frequency of monitoring visits and frequency of record monitoring.  
16. 
MEDICAL MONITORING 
The medical monitor will review results throughout the clinical trial as necessary to ensure the 
continued safety of the device and to ensure that no subjects are exposed to unreasonable risk.  
The medical monitor will be available to answer all questions from investigators.  The medical 
monitor will review and assess any reports of serious and/or device-related adverse events as well 
as device deficiencies that could have led to a serious adverse event and discuss these with the 
reporting investigator(s) as necessary.  The medical monitor, as well as any other qualified 
personnel designated by the Sponsor, shall also review study reports.   
17. 
PUBLICATIONS 
Refer to the Clinical Trial Agreement for information regarding JJSV publication policies. 
18. 
RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
RISKS OF THE TECNIS® TORIC II INTRAOCULAR LENS 
The acrylic 1-piece IOL TECNIS Toric II (ZCU Series) is designed to have improved rotational 
stability relative to the currently marketed TECNIS Toric 1-piece IOL (ZCT Series). The lenses are 
made from the same SENSAR soft acrylic material that is used in marketed TECNIS 1-piece 
lenses. Its aspheric anterior surface is intended to compensate for corneal spherical aberration. 
The risk documentation for the currently marketed TECNIS 1-piece lenses, ZCB00 and ZCT 
Series, is applicable. For ZCB00 and ZCT lenses, current risk documentation concludes that all 
risks are identified as low or medium and deemed acceptable.  
An additional risk assessment for the TECNIS Toric II was conducted to analyze potential 
hazardous situations resulting from the design differences compared to the ZCB00 and ZCT 
designs. With the implementation of a Risk Control Plan under this risk assessment, no additional 

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safety issues have been identified for the study products for their intended use in the proposed 
clinical investigation. 
GENERAL RISKS OF CATARACT SURGERY AND IOL IMPLANTATION 
There are risks and complications associated with cataract surgery and IOL implantation in 
general. These can include worsening of vision, hemorrhage, loss of corneal clarity, inflammation, 
infections, retinal detachment, pupil changes, glaucoma, etc. Complications can result in poor 
vision, loss of vision or loss of the eye.  
RISK MANAGEMENT 
Subjects will be closely monitored throughout the trial duration. The occurrence of adverse events 
and complaints will be assessed at each study visit and reported to JJSV according to Section 
11.0, Adverse Events and Product Complaints. Additionally, JJSV will monitor incoming data 
following the procedures outlined in Section 15.0, Monitoring. The Medical Monitor will ensure 
subjects are not exposed to additional risks by monitoring serious adverse events, device-related 
adverse events, and device-deficiencies that could have led to serious adverse events (Section 
15.3, Safety Monitoring).  
POTENTIAL BENEFITS 
The general clinical performance of the TECNIS Toric II is expected to be similar to the TECNIS 
Toric ZCT lens series. The primary benefit from implantation of the TECNIS Toric II is the correction 
of astigmatism following removal of the natural crystalline lens due to cataract. 
CONCLUSION 
The hazards/risks associated with the TECNIS Toric II are acceptable and within those of JJSV’s 
currently marketed IOLs. The potential clinical benefits of the TECNIS Toric II IOL outweigh the 
residual risks when the devices are used as intended.  
19. 
RECORDS RETENTION 
All study-related correspondence, subject records, consent forms, Authorization for 
Use/Disclosure of Health Information Forms or similar medical treatment privacy law 
documentation, records of the distribution and use of all study products, and original case report 
forms should be maintained by the investigator.   
The investigator must maintain and have access to the following essential documents until notified 
by the Sponsor.   
NOTE:  This may be for a minimum of 15 years after completion of the study.  The Sponsor requires 
notification if the investigator wishes to relinquish ownership of the data so that mutually agreed-
upon arrangements can be made for transfer of ownership to a suitably-qualified, responsible 
person. 

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• 
All case report forms within the EDC system 
• 
All adverse event information (i.e., medical records, medical reports and/or judgments from 
colleagues or outside specialists who assisted in the treatment and follow-up of the subject) 
• 
Study lens supply records/inventory 
• 
IRB approval documentation 
• 
Study correspondence  
• 
Study agreements 
• 
Site visit documentation 
• 
Protocol(s) and the reason for any deviations from the protocol 
• 
Subject log(s) 
• 
Completed subject ICFs and HIPAA authorizations 
• 
Subject medical chart/clinic notes  
20. 
TERMINATION OF THE INVESTIGATION 
JJSV can suspend or terminate the clinical investigation at any time for reasons it determines 
appropriate.  Additionally, the investigator, or JJSV, may stop a subject’s participation at any time.  
However, no suspension of the study would be made to disadvantage the study subjects.  
Following suspension of the study for any reason, all study subjects who have already received 
treatment would continue to be followed through completion of the study visit schedule.  
21. 
STATISTICAL METHODS 
This section highlights the analyses to be performed for key study endpoints. 1-Week 
postoperative visit will be the key timeframe for rotational stability.  The final 3-month postoperative 
visit will be the key timeframe for visual acuity, refraction and questionnaire. Data from other study 
visits (other than key timeframe) may be reported for supportive analysis.  All complications and 
adverse events will be evaluated at all visits. 
Descriptive statistics will typically include mean, standard deviation, median, minimum, maximum 
for continuous data with frequency and proportion reported for categorical data.    
21.1 
ANALYSIS POPULATION 
For monocular endpoints, all eyes implanted with a study toric IOL (model ZCU150 through 
ZCU600) will be pooled together for analysis; which include both study eyes from bilaterally 
implanted subjects and one study eye from unilaterally implanted subjects.  For binocular 
endpoints (i.e., binocular visual acuity and patient satisfaction questionnaire), only bilaterally 

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implanted subjects will be included for analysis.  Available data will be used for analysis (i.e., no 
data imputation for missing data). 
For the rotational stability endpoint, the primary analysis population will be all eyes implanted with 
a study toric IOL (model ZCU150 through ZCU600) and with available valid axis data at the 1-
week visit.  
 
 
 
 
 
 
 
21.2 
PRIMARY ENDPOINT 
PROPORTION OF EYES WITHIN 5 DEGREES OF ABSOLUTE IOL ROTATION 
The primary endpoint for this study is the amount of absolute axis rotation from operative axis to 
the 1-week visit as measured by the photographic axis method.  The proportion of eyes with less 
than or equal to 5 degrees of absolute rotation at 1-week will be reported along with the 95% 
confidence interval for this proportion.   
The clinical success criterion will be that 90% of eyes will have lens rotation of 5 degrees or less 
at 1-week using the photographic measurement method. 
The primary study endpoint is based on objective analysis of study photographs by designated 
sponsor personnel. 
 
 
 
 
 
 
 
21.3 
OTHER ENDPOINTS 
Rotational Stability  
In addition to the absolute axis rotation at 1-week, data will also be reported at 1 day and 3 months. 
The proportion of eyes within 5º for all postoperative visits as well as the proportion of eyes with 
less than 10º, 20º and greater than 30º of rotation will be reported. Mean absolute rotation will also 
be reported for all visits using descriptive statistics.  
Visual Acuity 
For visual acuity, the values will be converted to LogMAR prior to analysis. Descriptive statistics 
for all eyes will be reported for mean LogMAR monocular uncorrected and best corrected distance 

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visual acuity. The frequency and proportion of eyes achieving each acuity line will also be reported 
for uncorrected and best corrected distance visual acuity.   
Residual Refraction 
Descriptive statistics will be reported for mean refractive cylinder, cylinder vs intended cylinder, 
spherical equivalent and spherical equivalent vs intended and for percent reduction in cylinder for 
all eyes. In addition, the frequency and proportion of eyes within 0.50 D and within 1.00 D of 
intended values will be reported for refractive cylinder and spherical equivalent.    
Adverse Events 
The frequency and proportion of eyes with medical/lens findings or adverse events will also be 
reported. 
Other Findings 
Enrollment data, demographic data, accountability data and operative complications/ procedures 
will be reported using descriptive statistics. 
Patient Satisfaction and Investigator Satisfaction Questionnaires 
For questionnaires, the frequency and proportion with each response will be reported for the 
individual items on the questionnaire.   
21.4 
INTERIM REPORTS 
Multiple interim study analyses may be conducted during the study. 
21.5 
SAMPLE SIZE CALCULATIONS 
With 200 eyes, the two-sided 95% confidence interval for the proportion of eyes within 5 degrees 
of absolute rotation at 1-week will extend within 3.0% from the observed proportion assuming an 
expected proportion of 95% or higher.   

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APPENDIX A: SUMMARY OF PROCEDURES REQUIRED AT EACH VISIT 
Examination 
Preop 
Both eyes 
Op 
1st & 2nd 
eyes 
1 day 
1st & 2nd 
eyes 
1 Wk 
1st & 2nd 
eyes 
3M 
Both eyes 
Informed consent, ocular history, inclusion/exclusion criteria 
potential visual acuity, targeted refraction, IOL power calculations 
and biometry 
X 
 
 
 
 
Lens power/serial number, operative procedures 
 
X 
 
 
 
Manifest refraction  
X 
 
 
X 
X 
UCDVA – photopic, monocular  
 
 
X 
X 
X 
UCDVA - photopic, binocular  
 
 
 
 
Xa 
BCDVA - photopic, monocular  
X 
 
 
X 
X 
Surgical microscope photographs 
 
X 
 
 
 
Keratometry 
X 
 
  
X 
X 
Intraocular pressure 
X 
 
X 
X 
X 
Slit lamp exam 
X 
 
X 
X 
X 
Pupil Size (Dilated) 
X 
 
X 
X 
X 
Slit lamp retroillumination photographs (dilated) 
 
Xb 
X 
X 
X 
Slit lamp lens axis measurement (dilated) 
 
 
X 
X 
X 
Fundus exam  
X 
 
Xc 
Xc 
X 
Ocular/visual symptoms (non-directed) 
X 
 
X 
X 
X 
Patient Satisfaction Questionnaire (PSQ) 
 
 
 
 
Xa 
Investigator Satisfaction Questionnaire (ISQ) 
 
 
 
X 
X 
Complications/Adverse Events 
X 
X 
X 
X 
X 
a Only in subjects bilaterally implanted with the study lens 
b In cases, where good quality photographs are unattainable through surgical microscope or per PI discretion 
c Fundus exam required only if medically indicated 

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APPENDIX B: EQUIPMENT LIST 
The following equipment will be supplied to an investigative site for the duration of the study 
provided that the site does not already have such equipment available for use.  This equipment 
loan will be documented in the Clinical Study Agreement, which indicates that the equipment is 
to be returned to JJSV at the completion of the study. 
• 
M&S Technologies CTS-1000 Smart System© Computerized Vision Testing System, 
including laptop computer, tablet, near chart overlays, and glare bracket (“M&S System”) 
• 
Digital slit-lamp camera  
• 
Surgical microscope camera 
• 
Slit lamp compatible with slit-lamp camera 
 
 

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APPENDIX C: INSTRUCTIONS FOR CAPTURING PHOTOS THROUGH THE SURGICAL 
MICROSCOPE 
1) Take photos at the end of surgery when the IOL is in its final position.  
2) Pupil should be dilated enough to see IOL dots on both sides of the lens. Make sure 
wound sealing / corneal ink marking do not obscure the IOL dots. 
3) Eye should be centered in frame with sclera visible through 360°. 
4) Eye should be looking directly towards camera. 
5) Camera should be focused on iris and limbal features. 
6) The IOL dots will be slightly posterior to (behind) the focal plane, i.e. they may be slightly 
out of focus. 
7) Ensure you can see IOL axis alignment marks on both sides, magnification shows sclera 
on both sides, iris and scleral vessels are in focus. 
8) Press ‘FREEZE/FLASH’ button, review image and save good quality images. Make sure 
to capture three good quality images per eye.  
 
 
 

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APPENDIX D: INSTRUCTIONS FOR USING M&S SYSTEM 
Distance visual acuity testing will be performed using the ETDRS chart presented in the M&S 
System. The ETDRS is a LogMAR chart with proportionally spaced Sloan letters at 100% contrast 
for high contrast visual acuity.  Each presentation is randomized and is consistent and repeatable. 
The system is calibrated for test distance to subject and pixels/inch so that optotypes precisely 
follow ANSI Z80.21-2010 and ISO 8596:2000 with regard to size, spacing between optotypes and 
spacing between lines.    
Example of LogMAR 4.0 meter chart screen
 
The M&S System background screen luminance is automatically calibrated to 85 cd/m2 (range of 
80-110 cd/m2 is acceptable) for photopic testing.  Room lights should be off, and any other 
necessary lighting should be dim or dark (to levels lower than the illumination from the laptop 
screen) to maximize pupil size.  No surface (including reflective surfaces) within the subject’s field 
of vision should be brighter than the chart background in luminance.  The room lighting and screen 
luminance will be verified each time the computer is turned on using the JJSV-provided, auto-
adjusting, monitor-calibration system to ensure light levels are appropriate.  
The M&S System will be set up to perform required visual tests in a specific order, with prompts 
on the screen to allow the technician to set up the subject for monocular or binocular testing, 
refraction adjustments as needed and uncorrected or best-corrected testing.  Letters on all charts 
will appear randomly, with the technician controlling movement through charts based on subject 
responses.  
As a subject completes a visual acuity line, the technician will select the total number of letters 
correctly read for that line on the handheld controller, press “Enter” and then confirm the number 
of letters correct at the next prompt.  The M&S System will then advance to the next line of testing 
and the process will repeat.  The system will end the test when the subject no longer has any 
correct responses.  The number of letters correctly read will be displayed on the laptop screen, 
along with the LogMAR value and Snellen acuity.  Record the total number of letters read.  Once 
a test is completed, follow the prompts on the computer screen to start the next test. 
Test results are stored in the M&S computer and a hard copy will be printed and validated as a 
back-up. 

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APPENDIX E: INSTRUCTIONS FOR DISTANCE VISUAL ACUITY TESTING 
For distance visual acuities, the M&S System laptop should be placed at a test distance of 4.0 
meters from the subject.  A laptop setting may be used to reverse charts for rooms that require 
“folding” via a mirror to reach a distance of 4.0 meters.  Whether standard or “folded”, measure 
and record the test distance accurately.  If the room set-up does not allow the computer to be 
placed at precisely 4.0 meters, the M&S System can be adjusted to account for the actual test 
distance used. 
The M&S System will be set up to perform the required distance visual acuity tests in a specific 
order, with prompts on the screen to allow the technician to set up the subject for monocular or 
binocular testing, refraction adjustment as needed and uncorrected or best-corrected testing.  A 
phoropter may be used for distance acuity and refraction testing.  
Subjects should be reminded prior to testing that squinting or head-tilting is not allowed, as these 
can increase depth of focus by partially obstructing the pupil.  The technician is to monitor the 
subject to prevent and ensure that the subject is not squinting or tilting his or her head forward or 
sideways to read letters during visual acuity testing.  If either behavior is observed, the subject is 
to be reminded by the testing technician not to do so.   
Distance visual acuity measurements are to be performed per the visit schedule in Appendix A.  
To test subjects monocularly, occlude the second eye in the phoropter or with an occluder if trial 
lenses are used.   
Visual acuity measurements are based on the total number of correctly read letters.  Subjects 
should be persuaded to read the smallest letters possible even if they must guess.  Follow the 
testing process listed in Appendix D and refraction adjustments listed in Appendix G.  At the 
end of the test, the number of letters correctly read will be displayed on the laptop screen, along 
with the LogMAR value and Snellen acuity.  Record the total number of letters read in the EDC 
system.   
 
 
 
 
 
 
 
 
 

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APPENDIX F: MAXIMUM PLUS MANIFEST REFRACTION TECHNIQUE WITH 
CYLINDER REFINEMENT  
Manifest refraction testing will be performed using the M&S System ETDRS chart, with the room 
lighting set lower than the chart lighting level.   
NOTE: Objective refraction by either retinoscopy or autorefraction can be used as a starting point 
for the Manifest Refraction. Always ensure that the endpoint of refraction is maximum plus (or 
minimum minus) power that yields best visual acuity. 
1) Occlude the fellow eye. 
2) SPHERE: Starting with the objective refraction, refine the sphere to yield best visual acuity.   
NOTE: Add plus power (or reduce minus) until subject demonstrates at least a 1-line loss from 
best visual acuity (fogging). Then step down to the most plus (or least minus) sphere power 
until visual acuity and clarity show no improvement. 
3) CYLINDER AXIS: Refine cylinder with a cross-cylinder and the objective cylinder refraction 
as the starting point.  Refine axis first and power second, since the correct axis can be found 
with an incorrect power, but the correct power cannot be found with an incorrect axis.  
a. Direct the subject’s attention to 1 line above (larger letters) the best visual acuity.  
With the trial cylinder (axis and power) in the phoropter, introduce cross-cylinder 
for axis refinement.  When asking the subject which cross-cylinder axis position is 
better, “one or two?”, remind the subject to look at different letters on the line and 
report preference based on the overall clarity of the letters.  
b. Refine the axis based on the subject’s responses, using small steps (less than five 
degrees), until the subject reports no difference in the two choices. 
c. Cylinder axis may be further confirmed by bracketing:  Slowly rotate the trial 
cylinder in one direction until the subject reports blurring and note the axis.  Rotate 
the trial cylinder in the opposite direction past the presumed axis until the subject 
reports blurring, again noting the axis. The average of the two noted axes can be 
taken as the final astigmatism axis. 
4) CYLINDER POWER:  Set the cross cylinder to refine cylinder power and present choices to 
the subject, reminding the subject to look at different letters on the line and report preference 
based on overall clarity of the letters.  Reduce or increase trial cylinder power accordingly.  
a. Maintain the spherical equivalent throughout cylinder power refinement by 
adjusting the sphere once for every two clicks of cylinder power change. 
5) SPHERE CHECK: Introduce plus sphere with approximately 0.75 D to 1.00 D so the subject 
reports and demonstrates a reduction in visual acuity.  Then reduce sphere power in 0.25 D 
steps until visual acuity and clarity show no improvement. 
 

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APPENDIX G: REFRACTION ADJUSTMENTS FOR VISUAL ACUITY TESTING 
Postoperative study manifest refractions are to be performed using the M&S System at a distance 
of 4.0 meters.  Because 4.0 meters is not a distance that is equivalent to optical infinity, refraction 
adjustments are necessary to ensure proper vision testing that accounts for differences between 
the test distance and refraction distance.  The adjustment required (in diopters) is 1/test distance 
(in meters).  To adjust a 4.0-meter refraction to optical infinity, -0.25 D is to be added to the sphere 
of the refraction to obtain a true distance (infinity) correction.  On the other hand, to adjust optical 
infinity to a 4.0-meter test distance, +0.25 D is to be given.  In the case where the refraction 
distance (4.0 meters) and the vision test distance (4.0 meters) are the same, no adjustment is 
necessary.  The following table lists the refraction adjustments required for the various vision tests 
that are required for this study: 
Refraction Adjustments for Visual Acuity Testing 
 
Vision Test 
Test 
Distance 
Adjustment for Test Distance 
Uncorrected distance visual acuity (UCDVA) 
4.0 m 
+0.25 D adjustment only 
Best-corrected distance visual acuity (BCDVA) 
4.0 m 
No adjustment; ETDRS Rx only 
(phoropter) 
 
 
 

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APPENDIX H: SLIT LAMP EXAM RATINGS 
A.  Ratings of Aqueous Cells and Flare: For consistency across study sites, the SUN 
(Standardization of Uveitis Nomenclature) Working Group Grading Scheme a is to be used for 
grading of anterior chamber cells and flare.  
CELLS 
Grade 
Cells in Field (Field is a 1x1 mm slit 
beam) 
0 
<1 
0.5+ 
1 - 5 
1+ 
6 - 15 
2+ 
16 - 25 
3+ 
26 - 50 
4+ 
>50 
 
FLARE 
Grade 
Description 
0 
None 
1+ 
Faint 
2+ 
Moderate (iris and lens details clear) 
3+ 
Marked (iris and lens details hazy) 
4+ 
Intense (fibrin or plastic aqueous) 
a Standardization of uveitis nomenclature for reporting clinical data.  Results of The First International Workshop; The 
standardization of uveitis nomenclature (SUN) working group. Am J Ophthalmol 2005;140:509-516. 
 B. Ratings of Corneal Edema: Corneal edema should be classified according to the haziness 
of the epithelium, the number of microcysts observed, and the clouding of the stroma. 
Amount 
Grade 
Description 
None 
0 
Normal transparency: 
a. No epithelial or sub-epithelial haziness 
b. No microcysts 
c. No stromal cloudiness 
Trace 
+1 
a. Barely discernible localized epithelial or sub-epithelial haziness, 
and/or 
b. 1 to 20 microcysts, and/or 
c. Barely discernible localized stromal cloudiness 
Mild 
+2 
a. Faint but definite localized or generalized epithelial, sub-
epithelial or stromal haziness/cloudiness, and/or 
b. 21-50 microcysts 
Moderate 
+3 
a. Significant localized or generalized epithelial, sub-epithelial or 
stromal haziness/cloudiness and/or 
b. 51-100 microcysts 
Severe 
+4 
a. Definite widespread epithelial or stromal cloudiness, giving dull 
glass appearance to cornea or numerous coalescent bullae 
(please note the number and location of bullae), and/or 
b. >100 microcysts or bullae, and/or 
c. Numerous striae (please note the number and location of striae 
or folds) 

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C.  Posterior Capsule Striae Grading Scale: The following five-point grading scale is to be 
used for rating striae in the posterior capsule. 
Amount 
Grade 
Description 
None 
0 
None 
Trace 
+1 
One detectable, barely noticeable striae 
Mild 
+2 
One or two prominent striae 
Moderate 
+3 
Three or more prominent striae, but visibility of retina is 
not impacted 
Severe 
+4 
Three or more prominent striae affecting visualization of 
retina 
D.  Posterior Capsule Opacification Grading Scale: Below is the five-point grading scale to 
be used for PCO determination. 
Amount 
Grade 
Description 
None 
0 
Normal posterior capsule with no area of opacity.  Red reflex 
bright. 
Trace 
+1 
Some loss of transparency involving the posterior capsule.  
Red reflex fairly bright 
Mild 
+2 
Mild loss of transparency with cloudiness extending through 
most of the posterior capsule.  There may be a few Elschnig’s 
pearls in the posterior capsule.  Red reflex mildly diminished. 
Moderate 
+3 
Moderate loss of transparency with difficulty visualizing the 
retina.  There may be multiple Elschnig’s pearls in the 
posterior capsule.  Red reflex markedly diminished. 
Severe 
+4 
Posterior capsule very opaque with inability to view the retina.  
The posterior capsule may have confluent Elschnig’s pearls 
and fibrous scarring.  Red reflex barely visible. 
E.  IOL Glistenings: Use the following scale to grade IOL glistenings, using a slit beam 2.0 mm 
wide and 10.0 mm long. 
Amount 
Grade 
Description 
None 
0 
No glistenings visible 
Rare 
+0.5 
<10 glistenings visible 
Trace 
+1 
10-19 glistenings visible 
Mild 
+2 
20-29 glistenings visible 
Moderate 
+3 
30-39 glistenings visible 
Severe 
+4 
≥40 glistenings visible 
 
 
 

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APPENDIX I: SLIT LAMP RETROILLUMINATION PHOTOGRAPHS 
Slit lamp photographs should be captured at each postoperative visit. Photographs will be 
analyzed to determine the IOL rotation from baseline orientation (operative photograph). The 
analysis procedure requires alignment of postoperative images based on landmarks identified on 
the limbus, iris and/or sclera. All photographs must meet the following guidelines in order to be 
analyzable. To ensure accuracy, the following procedures detail the process for taking 
retroillumination photographs in a manner that captures both the iris/sclera and the toric IOL 
axis markers.  
1. The goal is to obtain images with enough magnification (usually 10X is optimal) and sufficient 
illumination to show sclera beyond the iris. Please take all images at the same slit lamp 
magnification (i.e., don’t alternate between 10X and 16X magnification).  
2. Pupils should be adequately dilated such that the IOL fiducial marks are visible on both sides. 
It is preferable to have more than one IOL axis mark visible on each side, however, at least 
one axis mark visible on each side of the IOL should be visible.  
3. To help identify individual subject photographs, prior to the photographic session for each eye, 
take a photograph of the study subject photo ID information. Identification cards with this 
information will be provided for each study subject.  
4. Use a short, intense slit beam to obtain a sufficiently bright red reflex (this is needed to 
visualize the IOL fiducial marks). Position the beam in such a way that the specular beam 
reflection does not obscure the IOL axis marks (ideally the beam should be entirely within the 
optic zone of the IOL). Use a second light source (such as an ophthalmoscope or LED lamp) 
for additional illumination to clearly visualize the iris and sclera.  
5. Focus the image such that the iris and sclera are clear. The plane of best focus should be 
aligned with the limbal blood vessels and iris.  
NOTE: Make sure large areas of limbus are not obscured by eyelids or from the shadow of 
the slit lamp beam arm  
6. The IOL axis marks should be posterior to the plane of best focus, and reasonably clear to 
allow for subsequent analysis.  
NOTE: Some cameras allow you to focus the image before taking the picture by holding the 
shutter button slightly. If your camera allows this, first try focusing the image and then 
moving the slit lamp closer to/further away from the subject until the iris is in focus. 
7. If you obtain blurry images, first try to increase the amount of light on the subject’s eye using 
a gooseneck microscope illuminator, ophthalmoscope or other secondary light source.  
8. There may be some time delay between pressing the camera button and actual image 
capture; please ask subject to hold steady 1-2 seconds after camera click to avoid motion 
blur.  

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NOTE: Do not use any built-in camera flash as this will not illuminate the iris and sclera and 
may increase the chances of obtaining a blurry image or shadows.  
9. Always capture images with your camera’s maximum resolution and image quality settings.  
10. Capture multiple photos at each session. Images may appear good on the camera screen but 
may be of inadequate quality once they are transferred to a larger screen.  
NOTE: Three good quality photos per eye for every postoperative visit is required 
11. Store the photographs electronically on your computer and on the USB drive in the native 
format for your camera (e.g., jpeg, tiff or bmp – tiff or raw image format preferred). To establish 
the order and session in which they were taken, each photo file should be renamed using the 
subject’s identification number, eye, visit and picture number, for example:  
31001-OD-1D-1.jpg, 31001-OD-1D-2.jpg, 31001-OD-1W-2.jpg etc.  
Figure 1: Examples of images with: A) Inadequate focus and exposure (poor quality) B) 
Adequate focus and exposure of the same eye (good quality) 
A   
 
 
 
 
      B 
 
 
Figure 2: Examples of good quality images with adequate iris/scleral detail. 
 

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APPENDIX J: INSTRUCTIONS FOR LENS AXIS MEASUREMENT WITH A SLIT 
LAMP 
I) After dilating the pupil, check that the subject’s head plane is horizontal. 
o This step will be done for every patient measurement.  
o Have subject place their chin on the chin rest and forehead against the forehead 
strap.  
o Change slit beam to thin, long and horizontal.  
o Align slit beam with lower edge of the limbus of the right eye.   
o Without adjusting the slit lamp height and subject continuing fixation on the same 
spot, move to the left eye and check if the slit beam is aligned with the lower 
edge of the left eye limbus.  
o If the left eye limbus is not aligned with right eye limbus, then adjust subject head 
until reasonable alignment is achieved.  
o Align the slit lamp beam to the axis of the toric IOL marks. 
o Record the IOL axis orientation to the nearest degree from the slit lamp scale.  
 
 

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APPENDIX K: PATIENT SATISFACTION QUESTIONNAIRE (PSQ) 
Instructions 
• 
The following questions are about your far vision (more than 5 feet away) 
with both eyes. 
• 
Please answer the questions based on your experience with your far 
vision since your last visit to the clinic.  
• 
Please read each question carefully and answer as honestly as you can 
without the help of anyone.  
• 
For each question, please mark an 
 in the one box that is your 
answer. 
 
 
1) How often do you feel the need to wear eyeglasses or contact lenses to improve your far 
vision? 
 
None of the time 
  
A little of the time 
  
Some of the time 
  
Most of the time 
  
All of the time 
  
 
 
2) How satisfied or dissatisfied are you with your far vision WITHOUT eyeglasses or 
contact lenses? 
 
Very satisfied 
  
Satisfied 
  
Undecided  
  
Dissatisfied 
  
Very dissatisfied 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX L: INVESTIGATOR SATISFACTION QUESTIONNAIRE (ISQ) 
Instructions 
• 
This questionnaire is self-administered and should be completed by the investigator at 
the 1- week visit and the 3-month visit for each eye separately.  
• 
The purpose of this questionnaire is to collect your feedback on the clinical outcomes 
achieved in each eye implanted with the TECNIS® Toric II IOL (study lens).  
• 
For each question, please mark an 
 in the one box that is your 
answer. 
 
1) Please rate your overall level of satisfaction with the clinical outcomes achieved in the 
implanted eye.  
 
5- Very satisfied 
☐ 
4- Satisfied 
☐ 
3- Undecided  
☐ 
2- Dissatisfied 
☐ 
1- Very dissatisfied 
☐ 
 
If you marked “1- Very dissatisfied” or “2- Dissatisfied”, please specify reason. 
 
________________________________________________________________ 
 
2) Please rate your level of satisfaction with the rotational stability of the study lens in the 
implanted eye. 
 
5- Very satisfied 
☐ 
4- Satisfied 
☐ 
3- Undecided  
☐ 
2- Dissatisfied 
☐ 
1- Very dissatisfied 
☐ 
 
If you marked “1- Very dissatisfied” or “2- Dissatisfied”, please specify reason. 
 
________________________________________________________________ 
 
 
 
3) Please rate your level of satisfaction with the achieved uncorrected distance visual 
acuity in the implanted eye. 
 
5- Very satisfied 
☐ 
4- Satisfied 
☐ 
3- Undecided  
☐ 
2- Dissatisfied 
☐ 
1- Very dissatisfied 
☐ 
 
If you marked “1- Very dissatisfied” or “2- Dissatisfied”, please specify reason. 
 
________________________________________________________________ 

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APPENDIX M:  ADVERSE EVENT AND COMPLAINT REPORTING INSTRUCTIONS 
All adverse events and complaints related to using JJSV products must be reported to JJSV.   
ALL ADVERSE EVENTS AND COMPLAINTS: 
For events that are not considered serious or related to the study device: 
1. Record the event and/or complaint on the case report form that corresponds to the visit 
during which awareness of the event occurred.  Additionally, a complaint may be 
reported via a telephone call to JJSV. 
2. Send the completed case report form to JJSV in a timely manner 
SERIOUS ADVERSE EVENTS OR DEVICE DEFICIENCIES THAT MAY HAVE LED TO A 
SERIOUS EVENT 
In the event of a serious event (i.e., life- or sight-threatening incident) whether or not related to 
the device, or a device deficiency that may have led to a serious event, the investigator shall: 
1. Notify JJSV immediately (no more than 48 hours after learning of the event) as follows:  
a. Contact the following JJSV personnel by phone and/or email: 
 
 
 
b. Complete a Detailed Adverse Event Form and submit to JJSV  
 
NON-SERIOUS, DEVICE-RELATED EVENTS: 
For events that are not considered serious but are believed related to the study device (ADEs): 
1. Complete a Detailed Adverse Event Form 
2. Ensure the data are submitted to JJSV within a timely manner.  
 
 
 
 

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APPENDIX N: AMERICAN ACADEMY OF OPHTHALMOLOGY TASK FORCE CONSENSUS 
STATEMENT ON ADVERSE EVENTS FOR INTRAOCULAR LENSES 
 

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