Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
Phase: NA
Conditions: Cataract, Corneal Astigmatism
Sponsor: Johnson & Johnson Surgical Vision, Inc.

 
 
Study Protocol 
 
 
CLINICAL INVESTIGATION OF THE SAFETY AND 
EFFECTIVENESS OF AN INVESTIGATIONAL 
MODEL OF THE TECNIS® INTRAOCULAR LENS 
 
 
 
NCT Number: NCT03949335 
Document date: 12 May 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 the Safety and Effectiveness of an Investigational Model 
of the TECNIS® Intraocular Lens  
 
IDE Number: G190057 
 
PROTOCOL NUMBER:  SUR-CAT-652-2001 
 
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; 21CFR812, ISO 14155:2011 
and all other applicable FDA regulations; conditions of approval imposed by the 
reviewing Institutional Review Board (IRB), FDA or 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 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 
TITLE 
PAGE 
 
Table of Contents ....................................................................................................... ii 
Personnel and Facilities............................................................................................ iv 
1. 
Synopsis ......................................................................................................... 1 
2. 
Background/Introduction................................................................................ 8 
3. 
Clinical Hypothesis ......................................................................................... 8 
4. 
Study Design................................................................................................... 9 
5. 
Acronyms ........................................................................................................ 9 
6. 
Study Objectives and Endpoints .................................................................... 9 
6.1 
Primary Effectiveness Endpoint....................................................................... 9 
6.2 
Secondary Effectiveness Endpoints .............................................................. 10 
6.3 
Safety Endpoints .......................................................................................... 10 
6.4 
Other Endpoints............................................................................................ 11 
7. 
Study Products ............................................................................................. 12 
7.1 
Intraocular Lenses ........................................................................................ 12 
7.2 
IOL Implantation Systems ............................................................................. 16 
8. 
Study Population .......................................................................................... 16 
8.1 
Inclusion Criteria ........................................................................................... 16 
8.2 
Exclusion Criteria.......................................................................................... 17 
9. 
Investigator Selection ................................................................................... 18 
9.1 
Investigator Qualifications ............................................................................. 18 
9.2 
Investigator Obligations ................................................................................ 18 
9.3 
Investigator Approval .................................................................................... 19 
10. 
Experimental Plan ......................................................................................... 20 
10.1 Overview ...................................................................................................... 20 
10.2 Visit Schedule............................................................................................... 21 
10.3 Preoperative Procedures .............................................................................. 22 
10.4 Randomization and Study Masking ............................................................... 25 
10.5 Study Lens Supply........................................................................................ 26 
10.6 Operative Procedures ................................................................................... 26 
10.7 Postoperative Procedures ............................................................................. 28 
10.8 Exit of Subjects............................................................................................. 34 
10.9 Unscheduled Visits ....................................................................................... 35 
10.10 Protocol Deviations ....................................................................................... 36 
11. 
Adverse Events and Product Complaints .................................................... 36 
11.1 Adverse Event Definitions ............................................................................. 36 
11.2 Product Complaint/Device Deficiency Definition............................................. 38 
11.3 Adverse Event and Complaint Reporting Requirements................................. 38 
11.4 Causal Relationship ...................................................................................... 39 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
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11.5 Adverse Event Follow-up .............................................................................. 40 
12. 
Protocol Changes/Amendments .................................................................. 40 
13. 
Ethics Review and Patient Welfare............................................................... 41 
13.1 Institutional Review Board (IRB).................................................................... 41 
13.2 Informed Consent ......................................................................................... 41 
14. 
Documentation.............................................................................................. 41 
14.1 Source Documents ....................................................................................... 41 
14.2 Subject Confidentiality .................................................................................. 42 
14.3 Case Report Form Completion ...................................................................... 42 
14.4 Study Summary ............................................................................................ 43 
15. 
Monitoring ..................................................................................................... 43 
15.1 Data Monitoring ............................................................................................ 43 
15.2 Administrative Monitoring .............................................................................. 43 
15.3 Safety Monitoring.......................................................................................... 45 
16. 
Publications .................................................................................................. 45 
17. 
Risk Analysis ................................................................................................ 45 
18. 
Records Retention ........................................................................................ 46 
19. 
Termination of the Investigation .................................................................. 47 
20. 
Statistical Methods ....................................................................................... 47 
20.1 Analysis Population ...................................................................................... 47 
20.2 Key Study Endpoints .................................................................................... 49 
20.3 Other Endpoints............................................................................................ 54 
20.4 Site Poolability Analysis ................................................................................ 55 
20.5 Visual Acuity conventions and General Statistics ........................................... 55 
20.6 Interim Reports ............................................................................................. 56 
20.7 Sample Size Calculations ............................................................................. 56 
Appendix A Summary of Procedures Required at Each Visit ................................. 58 
Appendix B Equipment List ..................................................................................... 59 
Appendix C Refraction Adjustments ....................................................................... 60 
Appendix D Instructions for Using the M&S System .............................................. 61 
Appendix E Instructions for Distance Visual Acuity Testing .................................. 63 
Appendix F Instructions for Intermediate Visual Acuity Testing ............................ 64 
Appendix G Instructions for Near Visual Acuity Testing ........................................ 65 
Appendix H Instructions for Defocus Testing ......................................................... 66 
Appendix J Instructions for Pupil Size Measurements ........................................... 67 
Appendix K Instructions for Contrast Sensitivity Testing ...................................... 68 
Appendix L Slit-Lamp Exam Ratings ....................................................................... 70 
Appendix M Patient Reported Visual Symptoms Questionnaire (PRVSQ) ............. 73 
Appendix N Patient Reported Spectacle Independence Questionnaire (PRSIQ) ... 83 
Appendix O American Academy of Ophthalmology Task Force Consensus 
Statement on Adverse Events for Intraocular Lenses ...................... 87 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
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PERSONNEL AND FACILITIES 
SPONSOR: 
Johnson & Johnson Surgical Vision, Inc. (“JJSV”) 
 
 
 
 
 
 
SPONSOR PERSONNEL: 
 
 
 
Global Medical Director - Cataract 
Johnson & Johnson Surgical Vision, Inc. 
 
 
 
 
 
Director, Clinical Science, Implants 
Johnson & Johnson Surgical Vision, Inc. 
 
 
 
 
 
Study Manager 
Johnson & Johnson Surgical Vision, Inc. 
 
 
 
 
 
Senior Principal Clinical Scientist 
Johnson & Johnson Surgical Vision, Inc. 
 
 
 
 
 
Principal Biostatistician 
Johnson & Johnson Surgical Vision, Inc. 
 
 
 
 
 
 
EMERGENCY TELEPHONE NUMBERS: 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
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JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
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JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
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JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
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1. 
SYNOPSIS 
PROTOCOL: 
Clinical Investigation of the Safety and Effectiveness of an 
Investigational Model of the TECNIS® Intraocular Lens  
Protocol Number:  SUR-CAT-652-2001 
STUDY TREATMENTS: 
Investigational Lens:  
TECNIS IOL Model ZFR00V (presbyopia-correcting IOL 
made with OptiBlue material, which contains a 
violet-blocking chromophore) 
Control Lens:  
TECNIS IOL Model ZCB00 (colorless monofocal, Johnson 
& Johnson Surgical Vision, 
), 
commercially available 
STUDY OBJECTIVE: 
The purpose of this clinical trial is to evaluate the safety 
and effectiveness of the investigational IOL Model ZFR00V 
in comparison to a monofocal IOL. 
CLINICAL HYPOTHESIS: 
The investigational IOL Model ZFR00V will provide 
improved distance-corrected near visual acuity, as well as 
decreased spectacle wear compared to the monofocal 
control TECNIS 1-piece IOL Model ZCB00.  The mean 
best-corrected distance acuity of the investigational IOL 
Model ZFR00V will be non-inferior to that of the monofocal 
control IOL Model ZCB00.    
Complication and adverse event rates associated with the 
investigational IOL Model ZFR00V will be within the rates 
for posterior chamber IOLs given in ISO 11979-7:2018. 
 
OVERALL STUDY DESIGN: 
Structure: 
Prospective, multicenter, bilateral, three-way masked 
(sponsor, subject and evaluator), randomized clinical trial 
Number of sites: 
Up to 15 sites in the United States 
Duration: 
6 months postoperative follow-up 
Administration: 
Surgeons will perform routine, small-incision, cataract 
surgery and implant the study lenses using a 

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sponsor-recommended implantation system. Refractive 
target outcomes will be emmetropia for both eyes. 
Visit Schedule: 
Subjects will be randomized to a treatment group (masked) 
and bilaterally implanted with the same lens type; the 
second eye is to be implanted within 1 month of the first 
eye surgery. 
 
All subjects will undergo 9 scheduled visits:  Preoperative 
for both eyes; Operative, 1-day, and 1-week visits for each 
eye; and 1-month and 6-month visits for both eyes. 
STUDY POPULATION CHARACTERISTICS: 
Condition: 
Bilateral cataracts with otherwise-healthy eyes 
Number of Subjects: 
Up to 300 subjects (150 per lens group) will be enrolled, 
allowing for 10% screening failures, to achieve 
approximately 135 bilaterally-implanted subjects in each 
lens group. Allowing for 10% lost to follow-up, this will 
achieve approximately 122 evaluable subjects at 6 months 
postoperative in each lens group in the study. 
Each site should enroll approximately 20 subjects, and no 
site may enroll more than 25% of the enrollment total.  
 
Inclusion Criteria (all criteria apply to each study eye): 
• 
Minimum 22 years of age 
• 
Bilateral cataracts for which posterior chamber IOL implantation has been planned  
• 
Preoperative best-corrected distance visual acuity (BCDVA) of 20/40 Snellen or 
worse with a glare source or 20/40 Snellen or worse without a glare source  
• 
Potential for postoperative BCDVA of 20/30 Snellen or better 
• 
Corneal astigmatism: 
o Normal corneal topography  
o Predicted postoperative corneal astigmatism of less than 1.00 D in both eyes, 
including posterior corneal astigmatism (PCA) 
• 
Clear intraocular media other than cataract in each eye 
• 
Availability, willingness and sufficient cognitive awareness to comply with 
examination procedures and study visits 
• 
Signed informed consent and HIPAA authorization or equivalent documentation 
necessary to comply with applicable privacy laws pertaining to medical treatment in 
the governing countries 
• 
Ability to understand and respond to a questionnaire in English. 

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Exclusion Criteria (all criteria apply to each study eye): 
• 
Requiring an intraocular lens power outside the available range of +14.0 D  
to +26.0 D 
• 
Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or 
abnormally-shaped pupils)  
• 
Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, 
nystagmus, etc.) 
• 
Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, 
including prophylactic peripheral iridotomies and peripheral laser retinal repairs  
• 
Corneal abnormalities such as stromal, epithelial or endothelial dystrophies (e.g., any 
observed guttata) that are predicted to cause visual acuity losses to a level worse 
than 20/30 Snellen during the study 
• 
Irregular corneal astigmatism 
• 
Inability to achieve keratometric stability for contact lens wearers (as defined in 
Section 10.3 Preoperative Procedures)  
• 
Recent ocular trauma or ocular surgery that is not resolved/stable or may affect 
visual outcomes or increase risk to the subject 
• 
Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration 
or other retinal disorders) that are predicted to cause visual acuity losses to a level 
worse than 20/30 Snellen during the study 
• 
Subjects with conditions associated with increased risk of zonular rupture, including 
capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as 
pseudoexfoliation, trauma, or posterior capsule defects 
• 
Use of systemic or ocular medications that may affect vision 
• 
Prior, current, or anticipated use during the course of the 6-month study of 
tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) 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) 
• 
Poorly-controlled diabetes 
• 
Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the 
opinion of the investigator, would increase the operative risk or confound the 
outcome of the study (e.g., immunocompromised, connective tissue disease, 
suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular 
inflammation, etc.).  Note: controlled ocular hypertension without glaucomatous 
changes (optic nerve cupping and visual field loss) is acceptable. 
• 
Known ocular disease or pathology that, in the opinion of the investigator,  
o may affect visual acuity 
o may require surgical intervention during the course of the study (macular 
degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled 
glaucoma, etc.) 
o may be expected to require retinal laser treatment or other surgical intervention 
during the course of the study (macular degeneration, cystoid macular edema, 
diabetic retinopathy, etc.) 
• 
Pregnancy, planned pregnancy, presently lactating, or another condition associated 
with hormonal fluctuation that could lead to refractive changes 
• 
Concurrent participation or participation within 60 days prior to preoperative visit in 
any other clinical trial 

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• 
Desire for monovision correction. 
EVALUATION CRITERIA: 
The purpose of this clinical study is to evaluate the safety and effectiveness of the 
investigational IOL Model ZFR00V.  Clinical endpoints and success criteria for this 
evaluation are defined below. 
EFFECTIVENESS  
The primary effectiveness endpoint for the study is the mean monocular 
distance-corrected near visual acuity (40 cm) under photopic conditions.  
 
 
 
 
 
The secondary effectiveness endpoints for the study are: 
1. Monocular DCIVA (66 cm) under photopic conditions 
 
 
 
 
2. Monocular DCNVA (33 cm) under photopic conditions 
 
 
 
 
 
3. Monocular BCDVA under photopic conditions 
 
 
 
4. Monocular distance-corrected defocus curve 
 
 
5. Spectacle wear 
 
 
 
 
 
 
 
 

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SAFETY  
Primary Safety: 
1. 
The rate of secondary surgical interventions (SSIs) related to optical 
properties of the lens in first eyes of subjects in the test group
 
 
   
2. 
All SPE types of adverse events, including total SSIs, reported among first 
eyes of subjects in the test group will be compared to ISO SPE rates.  
 
 
 
 
3. 
All other types of adverse events (non-SPE) will be analyzed 
 
 
 
Co-Primary Safety: 
1. 
The proportion of first eyes in the test group that achieves monocular BCDVA 
percent of 20/40 or better will be compared to the ISO SPE rate. 
Secondary Safety: 
The binocular and monocular (first eyes) best-corrected distance contrast 
sensitivity for the test group will be compared to that of the control (mesopic 
with and without glare at 1.5, 3, 6, and 12 cpd, photopic with glare at 3, 6, 12, 
and 18 cpd).  
For primary and co-primary safety endpoints, additional secondary analyses consisting 
of second eyes and all eyes (pooling first and second eyes) will also be included. 
OTHER ENDPOINTS 
Other endpoints in the study include: 
• 
Binocular distance-corrected defocus  
• 
Monocular (first eye) and binocular mesopic DCNVA at 40 cm 
• 
Monocular (first eye) UCDVA 
• 
Binocular UCDVA, UCIVA, and UCNVA  
• 
Binocular BCDVA and DCNVA at 40 cm 
• 
Medical findings/complications  
• 
Lens findings/complications  
• 
Residual refractive error  
• 
Visual symptoms reported via PRO instrument (Patient Reported Visual Symptoms 
Questionnaire [PRVSQ] 
• 
Ocular/visual symptoms (non-directed responses to the open-ended question “Are 
you having any difficulties with your eyes or vision?”)  

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• 
Satisfaction and other questionnaire responses  
DATA ANALYSIS: 
The investigational IOL Model ZFR00V will be compared to the control IOL Model 
ZCB00.  The 6-month postoperative visit is the key analysis time point for all endpoints, 
although data will be reviewed at other time points as well.   
For the primary effectiveness endpoint (DCNVA at 40 cm) and monocular secondary 
effectiveness endpoints (DCIVA, DCNVA at 33 cm, and BCDVA), the primary analysis 
population will be a modified Intent-to-Treat (mITT) analysis for all first eyes randomized 
and implanted with either a test or control lens.   
For the spectacle wear secondary endpoints based on binocular measurements, the 
primary analysis population will be a modified Intent-to-Treat (mITT) analysis that only 
includes subjects randomized and binocularly implanted with the same lens model 
(either investigational or control lenses in both eyes).  Any missing values at the 6-month 
postoperative visit will be imputed in ITT and mITT analyses.   
Since there are no inferential statistics for the monocular defocus curve secondary 
endpoint, a safety population (SP), with available data (i.e., no data imputation) and with 
subjects randomized and implanted with either an investigational or control lens  will be 
the primary analysis population.  The SP will also be used for safety endpoints and other 
endpoints.  With the exception of spectacle wear data, binocular, second-eye and pooled 
eye data will be considered supplementary and will be used for secondary analyses. 
Per-protocol analysis will be performed for primary and secondary endpoints.  Sensitivity 
analysis will also be performed for primary DCNVA (40 cm) endpoint and secondary 
DCIVA, DCNVA (33 cm), BCDVA, and spectacle wear endpoints.  Please see detailed 
descriptions of the analysis populations in Section 20.1. 
All data will be reported by IOL group.   
STUDY VISITS AND PROCEDURES: 
Inclusion and exclusion qualifications will be assessed at the preoperative visit according 
to the inclusion/exclusion criteria.  The Informed Consent Form and Authorization for 
Use/Disclosure of Health Information form (HIPAA authorization) must be signed by any 
patients who agree to participate in the study prior to undergoing any study-specific 
procedures.  Those subjects who meet the inclusion/exclusion criteria and agree to 
participate will be randomized to a treatment group in a masked fashion and implanted in 
both eyes: either the test Model ZFR00V IOL or control Model ZCB00 IOL.  The eye 
implanted first will be considered the primary study eye.  All subjects are intended to 
have bilateral cataract surgery with the second-eye surgery occurring after the 1-week 
exam for the first eye but no more than 30 days after the first eye surgery.  Study 
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will be masked for the duration of the study.  In addition, key Sponsor personnel will be 
masked during the study, as necessary. 
Key preoperative data include ocular health and history, visual acuities, manifest 
refraction, keratometry, biomicroscopic slit-lamp findings, ocular symptoms, and 
biometry.  The operative visit will include standard procedures for cataract surgery and 
IOL implantation.  Key postoperative data include monocular and binocular uncorrected 
and distance-corrected visual acuities under photopic and mesopic lighting conditions, 
contrast sensitivity, defocus curve, slit-lamp findings, non-directed visual symptoms, 
questionnaires, and adverse events.   
2. 
BACKGROUND/INTRODUCTION 
Presbyopia, defined as the age-related loss of accommodative amplitude1, affects 
essentially all human beings beyond the age of 45 and impacts the ability of the eye to 
focus at near distances2.  Current intraocular lens options for cataract patients who 
desire improved vision across a range of distances include a choice of monovision or 
multifocality.  Patients implanted with standard monofocal lenses often need spectacles 
for reading or performing other near tasks, even if a monovision option is selected.  
Patients implanted with multifocal lenses, while being able to read and perform other 
near tasks without spectacles, may have limited intermediate ability (e.g., may need 
spectacles to work on a computer), and may sometimes experience dysphotopsias (e.g., 
halos), particularly at night.  Some accommodating lenses are also available on the 
market, although their effect depends upon fit within the capsular bag or capsular bag 
elasticity. The extended range of vision IOL, TECNIS Symfony Model ZXR00, uses 
diffractive technology to elongate the depth of focus and improve vision range compared 
to standard monofocal IOLs.   
The investigational IOL in this protocol, Model ZFR00V, is a next-generation TECNIS 
lens that is designed to provide an increased range of vision for intermediate and near 
tasks as compared to the control IOL Model ZCB00.  
3. 
CLINICAL HYPOTHESIS 
The investigational IOL Model ZFR00V will provide improved distance-corrected near 
visual acuity, as well as decreased spectacle wear compared to the monofocal control, 
TECNIS 1-piece IOL Model ZCB00.  The mean best-corrected distance acuity of the 
 
 
1 Koretz J.F., Kaufman P.L, Neider M.W. Goeckner P.A.  Accommodation and Presbyopia in the Human Eye – Aging of 
the Anterior Segment.  Vision Res. 1989;29: 1685-1692. 
2 Benjamin, William, J., Borish, Irvin M. Borish’s Clinical Refraction, Philadelphia: 1998, W.B. Saunders, pg 109. 

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investigational IOL Model ZFR00V will be non-inferior to that of the monofocal control 
IOL Model ZCB00.   
Complication and adverse event rates associated with the investigational IOL Model 
ZFR00V will be within the rates for posterior chamber IOLs given in ISO 11979-7:2018. 
4. 
STUDY DESIGN 
This study is a 6-month, prospective, multicenter, three-way masked (Sponsor, subject 
and evaluator), bilateral randomized clinical investigation of the TECNIS IOL 
Model ZFR00V versus the TECNIS Model ZCB00 IOL.   
The study will be conducted at up to 15 sites in the U.S.A. and will enroll up to 
300 subjects to achieve approximately 270 bilaterally-implanted subjects, resulting in 
approximately 122 evaluable subjects in each lens group at 6 months.  Subjects will be 
randomized to a treatment group in a masked fashion and be implanted with either the 
investigational IOL Model ZFR00V or the control IOL Model ZCB00 in both eyes.  The 
eye implanted first will be considered the primary (monocular) study eye. 
5. 
ACRONYMS 
The following acronyms are used throughout this document:   
• 
UCDVA:  uncorrected distance visual acuity 
• 
BCDVA:  best-corrected distance visual acuity 
• 
UCIVA:  uncorrected intermediate visual acuity 
• 
DCIVA:  distance-corrected intermediate visual acuity 
• 
UCNVA:  uncorrected near visual acuity (40 cm) 
• 
DCNVA:  distance-corrected near visual acuity (40 cm unless otherwise stated) 
• 
D: diopters 
6. 
STUDY OBJECTIVES AND ENDPOINTS 
The purpose of this study is to evaluate the safety and effectiveness of the 
investigational IOL Model ZFR00V in comparison to a monofocal control IOL.  The 
6-month postoperative visit is the key analysis time point for all endpoints, although data 
will be reviewed at other time points as well.  Data for other visits will be included in the 
final analysis. 
6.1 
PRIMARY EFFECTIVENESS ENDPOINT 
MONOCULAR PHOTOPIC DCNVA AT 40 CM  
Success criteria:  Statistically significant improvement in mean monocular 
photopic distance-corrected near visual acuity for first eyes in the test group vs. 

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first eyes in the control group. In addition, clinical significance will be determined 
if the mean DCNVA for the test group is at least 0.2 LogMAR. 
 
6.2 
SECONDARY EFFECTIVENESS ENDPOINTS 
1. MONOCULAR PHOTOPIC DCIVA AT 66 CM  
Success criteria: Statistically significant improvement in mean LogMAR distance-
corrected intermediate visual acuity for first eyes in the test group vs. first eyes in 
the control group.  In addition, clinical significance will be determined if the mean 
DCIVA at 66 cm for the test group is at least 0.2 LogMAR. 
2. MONOCULAR PHOTOPIC DCNVA AT 33 CM 
Success Criteria:  Statistically significant improvement in mean LogMAR 
distance-corrected near visual acuity at 33 cm for the test group compared to the 
control group.  In addition, clinical significance will be determined if the mean 
DCNVA at 33 cm for the test group is at least 0.2 LogMAR. 
3. MONOCULAR PHOTOPIC BCDVA  
Success criteria: Statistically non-inferior (within 0.1 LogMAR) in mean LogMAR 
best-corrected distance visual acuity for eyes in the test group vs. eyes in the 
control group. 
4. MONOCULAR DISTANCE-CORRECTED DEFOCUS CURVE  
Success Criteria:  The mean distance-corrected visual acuity for the 
investigational lens group is maintained at 0.2 LogMAR or better from 0.0 D 
to -2.5 D of defocus. 
5. SPECTACLE WEAR 
Success criteria: Statistically significantly greater proportion of subjects who do 
not wear spectacles (defined as subjects who wear glasses or contacts “none of 
the time”) for distance, intermediate, near and overall vision in subjects in the test 
group vs. control group, as determined from a PRO instrument assessing 
spectacle wear (PRSIQ). In addition, clinical significance will be determined by 1) 
at least 50% of subjects in the test group will report wearing glasses “None of the 
time” for all four conditions (distance, intermediate, near and overall vision) and 
2) the proportion of test subjects who report wearing glasses or contacts “None 
of the time” for all four conditions will be at least 25 percentage points higher than 
that for the control group. 
 
6.3 
SAFETY ENDPOINTS 
Primary Safety: 

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1. The rate of SSIs related to optical properties of the lens in first eyes of 
subjects in the test group will be analyzed using descriptive statistics and 
compared to that of the control group.   
2. All SPE adverse events, including total SSI, reported among first eyes of 
subjects in the test group will be compared to ISO SPE rates.  
3. All other non-SPE AEs will be analyzed using descriptive statistics comparing 
the two lens groups.   
Co-Primary Safety: 
1. The rate of monocular BCDVA 20/40 or better among first eyes of subjects in 
the test group will be compared to ISO SPE rates.   
Additionally, secondary analyses consisting of second eyes and all 
investigational eyes (pooling first and second eyes together) will also be included 
for the above primary and co-primary safety endpoints. 
Secondary Safety: 
As a secondary safety endpoint, the binocular and monocular (first eyes) best-
corrected distance contrast sensitivity for the test group will be compared to 
control (mesopic with and without glare at 1.5, 3, 6, and 12 cpd, photopic with 
glare at 3, 6, 12, and 18 cpd). 
 
6.4 
OTHER ENDPOINTS 
Other endpoints in the study include: 
• 
Binocular distance-corrected defocus 
• 
Monocular (first eye) and binocular mesopic DCNVA at 40 cm 
• 
Monocular (first eye) UCDVA 
• 
Binocular UCDVA, UCIVA, and UCNVA 
• 
Binocular BCDVA and DCNVA at 40 cm 
• 
Medical findings/complications 
• 
Lens findings/complications  
• 
Residual refractive error 
• 
Visual symptoms reported via PRO instrument (Patient Reported Visual 
Symptoms Questionnaire [PRVSQ]) 
• 
Ocular/visual symptoms (non-directed responses to the open-ended question 
“Are you having any difficulties with your eyes or vision?”) 
• 
Satisfaction and other questionnaire responses  
 

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7. 
STUDY PRODUCTS 
7.1 
INTRAOCULAR LENSES  
The two intraocular lens models that will be evaluated in this study are the 
investigational IOL Model ZFR00V and the control IOL Model ZCB00.   
Investigational IOL Model ZFR00V  
The investigational IOL Model ZFR00V is a posterior chamber, 1-piece, aspheric, 
diffractive, acrylic, foldable IOL designed for placement in the capsular bag (Figure 1).  
The lens is made of OptiBlue hydrophobic acrylic material, which is a variant of the 
hydrophobic acrylic SENSAR material that is used for the material/mechanical 1-piece 
parent, the JJSV 1-Piece IOL Model AAB00, on which the TECNIS 1-piece monofocal 
IOL lens model ZCB00 is also based.  The ZFR00V lens has the same overall 
geometry/dimensions (13 mm overall length and 6 mm optic diameter) as the 
material/mechanical 1-piece parent monofocal IOL models.  The investigational ZFR00V 
lens also has the same TECNIS modified prolate (aspheric) design on the anterior optic 
surface as TECNIS diffractive multifocal and extended range of vision IOLs to reduce 
spherical aberration.   
Control IOL Model ZCB00  
The control IOL Model ZCB00 (Figure 2) shares the same material, general dimensions, 
geometry, and one-piece soft acrylic lens platform as the SENSAR 1-Piece IOL, Model 
AAB00, which is the mechanical parent of the ZFR00V IOL.   
Figure 1:  Drawing and Photograph of TECNIS IOL Model ZFR00V  
         
 
 
 
 

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Figure 2:  Drawing and Photograph of TECNIS IOL Model ZCB00 
 
 
Like all of JJSV’s 1-piece soft acrylic IOLs, investigational IOL Model ZFR00V and the 
control IOL Model ZCB00 have a surface treatment of polyethylene glycol (PEG) to 
reduce tackiness of the lens surface and include a ProTEC 360° barrier edge, the 
stability of Tri-Fix 3-point design, and a frosted-edge treatment.  
INDICATIONS FOR INVESTIGATIONAL IOL 
The Model ZFR00V is indicated for primary implantation for the visual correction of 
aphakia in adult patients with or without presbyopia, with less than 1 diopter of 
pre-existing corneal astigmatism, in whom a cataractous lens has been removed.  The 
lens mitigates the effects of presbyopia by providing improved intermediate and near 
visual acuity, while maintaining distance visual acuity comparable to that of an aspheric 
monofocal IOL.  The lens provides a full range of vision and increased spectacle 
independence.  The lens is intended for capsular bag placement only. 
INDICATIONS FOR CONTROL IOL 
The TECNIS monofocal IOL Model ZCB00 is indicated for the visual correction of 
aphakia in adult patients in whom a cataractous lens has been removed by 
extracapsular cataract extraction.  These devices are intended to be placed in the 
capsular bag. 
STORAGE AND DISTRIBUTION 
Consignments of the investigational study lens model will be supplied to the investigative 
sites.  All study lenses should be stored in the original packaging and kept in a dry place.  
Lenses should not be stored in direct sunlight or at temperatures greater than 45° C 
(113°F).  Each lens is packaged in a lens tray and sealed in a peel-pouch.  The lens is 
sterile as long as the package has not been opened or damaged and the shelf -life 

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expiration date has not been exceeded. The Principal Investigator is responsible for 
ensuring that the investigational lenses are used only for subjects enrolled in this study. 
COMPARISON CHART 
Table 1 describes the dimensional and optical similarities between the study lenses and 
other associated JJSV lenses. 

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7.2 
IOL IMPLANTATION SYSTEMS  
The investigational TECNIS IOL Model ZFR00V and the control TECNIS IOL Model 
ZCB00 lenses are to be implanted using the UNFOLDER Platinum-1 Series Implantation 
System (DK7796 handpiece with the UNFOLDER Platinum-1 Series cartridge, Model 
1MTEC30) or the ONE SERIES Ultra Implantation System (DK7786 or DK7791 
handpiece with the One Series Ultra cartridge, Model 1VIPR30).  
8. 
STUDY POPULATION 
All study subjects will be enrolled from the normal surgical cataract population at up to 
15 sites in the U.S.A.  Up to 300 subjects will be enrolled to achieve approximately 
270 bilaterally implanted subjects, resulting in approximately 244 evaluable subjects 
(122 subjects per lens group) at 6 months.  This allows for a screen failure rate of 
approximately 10% and a drop-out rate of approximately 10% for implanted subjects.  
Each site should implant a minimum of 20 subjects, and no site may implant more than 
25% of the enrollment total.   
This study will include only subjects undergoing bilateral primary cataract extraction and 
IOL implantation and who meet all of the study inclusion and exclusion criteria in both 
eyes.  Subjects who meet the eligibility criteria will be offered enrollment in the study.  
Eligibility criteria may not be waived by the investigator.  Any questions regarding patient 
eligibility are to be discussed with JJSV prior to subject enrollment.  Those subjects who 
meet the eligibility criteria and agree to participate will be randomized to receive either 
the investigational IOL Model ZFR00V or the control IOL Model ZCB00 in both eyes.  
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  
Note: All criteria apply to each eye 
• 
Minimum 22 years of age 
• 
Bilateral cataracts for which posterior chamber IOL implantation has been planned  
• 
Preoperative best-corrected distance visual acuity (BCDVA) of 20/40 Snellen or 
worse with a glare source or 20/40 Snellen or worse without a glare source  
• 
Potential for postoperative BCDVA of 20/30 Snellen or better 
• 
Corneal astigmatism: 
o Normal corneal topography 
o Predicted postoperative corneal astigmatism of less than 1.00 D in both eyes, 
including posterior corneal astigmatism (PCA) 
• 
Clear intraocular media other than cataract in each eye 
• 
Availability, willingness and sufficient cognitive awareness to comply with 
examination procedures and study visits 

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• 
Signed informed consent and HIPAA authorization or equivalent documentation 
necessary to comply with applicable privacy laws pertaining to medical treatment in 
the governing countries 
• 
Ability to understand and respond to a questionnaire in English  
8.2 
EXCLUSION CRITERIA  
Note: All criteria apply to each eye 
• 
Requiring an intraocular lens power outside the available range of +14.0 D  
to +26.0 D 
• 
Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or 
abnormally-shaped pupils)  
• 
Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, 
nystagmus, etc.) 
• 
Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, 
Including prophylactic peripheral iridotomies and peripheral laser retinal repairs  
• 
Corneal abnormalities such as stromal, epithelial or endothelial dystrophies (e.g., any 
observed guttata) that are predicted to cause visual acuity losses to a level worse 
than 20/30 Snellen during the study 
• 
Irregular corneal astigmatism 
• 
Inability to achieve keratometric stability for contact lens wearers (as defined in 
Section 10.3 Preoperative Procedures)  
• 
Recent ocular trauma or ocular surgery that is not resolved/stable or may affect 
visual outcomes or increase risk to the subject 
• 
Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration 
or other retinal disorders) that are predicted to cause visual acuity loss to a level 
worse than 20/30 Snellen during the study 
• 
Subjects with conditions associated with increased risk of zonular rupture, including 
capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as 
pseudoexfoliation, trauma, or posterior capsule defects 
• 
Use of systemic or ocular medications that may affect vision 
• 
Prior, current, or anticipated use during the course of the 6-month study of 
tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) 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) 
• 
Poorly-controlled diabetes 
• 
Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the 
opinion of the investigator, would increase the operative risk or confound the 
outcome(s) of the study (e.g., immunocompromised, connective tissue disease, 
suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular 
inflammation, etc.).  Note: controlled ocular hypertension without glaucomatous 
changes (optic nerve cupping and visual field loss) is acceptable. 
• 
Known ocular disease or pathology that, in the opinion of the investigator,  
o may affect visual acuity 
o may require surgical intervention during the course of the study (macular 
degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled 
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o may be expected to require retinal laser treatment or other surgical intervention 
during the course of the study (macular degeneration, cystoid macular edema, 
diabetic retinopathy, etc.) 
• 
Pregnancy, planned pregnancy, presently lactating, or another condition associated 
with hormonal fluctuation that could lead to refractive changes 
• 
Concurrent participation or participation within 60 days prior to preoperative visit in 
any other clinical trial 
• 
Desire for monovision correction 
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 TECNIS 1-piece IOLs in cataract patients.  Investigators 
should have established personalized A-constants for the TECNIS 1-piece IOL Model 
ZCB00.  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.  Investigator 
will make changes to a protocol only after notifying and obtaining approval from 
JJSV, the FDA and the Investigational 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 significant trial-related duties 
• 
Be responsible for protecting the rights, safety and welfare of subjects under the 
investigator’s care and be responsible for the control and documentation of the 
devices under investigation 
• 
Inform patients that the device(s) are being used for investigational purposes and 
that requirements relating to obtaining informed consent and IRB approval are met 
according to 21CFR50, 21CFR56, 21CFR812 and all other applicable laws and 
regulations 
• 
Maintain confidentiality as required by HIPAA or similar laws and regulations 
• 
Shall not obtain written informed consent from any subject to participate or allow any 
subject to participate before obtaining FDA and IRB approval 

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• 
Document in each subject’s case history that informed consent was obtained prior to 
participation in the study as required by 21CFR812 
• 
Report to JJSV and the reviewing IRB any adverse experiences that occur during the 
course of the study in accordance with applicable laws and regulations 
• 
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, PMDA, 
Health Canada, MOH, etc.) 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 as required by 21CFR812.150  
• 
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 
• 
Supervise and permit investigational device use and disposition in accordance with 
applicable regulations and protocol requirements.  Upon completion of enrollment or 
termination of the study or the investigator’s part of the study, or at JJSV’s request, 
return to JJSV any remaining supply of the investigational device 
• 
Provide sufficient accurate financial information to JJSV to allow JJSV to submit 
complete and accurate certification or disclosure statements as required by 
21CFR54.  Promptly update this information if any relevant changes occur during the 
course of 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 FDA regulations (e.g., 21CFR812), all other applicable laws and 
regulations, and all conditions of approval imposed by the reviewing IRB and the 
FDA 
• 
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, location of 
the investigational device(s), 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, informed consent forms 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.  Study sites will obtain IRB approvals and fulfill 
any other site-specific regulatory requirements.  The investigator is required to report to 

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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 
• 
Clinical Investigator Brochure Signature page 
• 
Financial Disclosure form 
• 
Signed and dated copy of investigator’s current curriculum vitae 
• 
Copy of the investigator’s current medical license  
• 
Hospital/Ambulatory Surgery Center Clinical Study Acknowledgement, if required 
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 U.S. Code of Federal Regulations, the 
Declaration of Helsinki, ISO 14155:2011 and all other applicable laws and regulations.  
The study will not begin until regulatory and IRB approvals have been obtained. 
This study will be a prospective, multicenter, bilateral, comparative, three-way masked 
(Sponsor, subject and evaluator), randomized clinical investigation conducted at up to 15 
sites.  Up to 300 subjects will be enrolled to achieve approximately 270 bilaterally 
implanted subjects, resulting in approximately 244 evaluable subjects (122 per lens 
group) at 6 months.  After informed consent is obtained and confirmation that all 
eligibility criteria are met, the eye(s) may be treated according to randomization.   
After signing the informed consent form, subjects meeting all eligibility criteria will be 
randomized in a masked fashion to a treatment group: either the investigational IOL 
Model ZFR00V or the control IOL Model ZCB00.  Prior to randomization, the investigator 
will choose which eye to operate on first for each subject at his/her discretion based on 
his/her standard clinical practice (e.g., the eye with the worse cataract, poorer 
best-corrected distance vision and/or more severe optical/visual complaints).  All 
subjects are intended to have bilateral cataract surgery with the second-eye surgery 
occurring after the 1-week postoperative exam for the first eye, but no more than 
30 days after the first eye surgery.  All subjects will be examined through 6 months 
postoperatively according to the visit schedule described in Section 10.2, Visit 
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Study evaluators responsible for conducting all vision testing will remain masked to 
which lenses were implanted through the 6-month study visit.  Because differences 
between the investigative and control lenses may be discernible upon slit-lamp 
examination, special care must be taken to maintain masking of subjects and study 
technicians.  As such, it is recommended that only the investigator, sub-investigator or 
other designated and trained clinician perform all biomicroscopic slit-lamp exams.  To 
maintain consistency, as well as masking, 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 subject should also remain masked to the randomized treatment 
throughout the study. 
Key preoperative data include ocular health and history, visual acuities, manifest 
refraction, keratometry, topography, biomicroscopic slit-lamp findings, ocular symptoms 
and biometry.  The operative visit will include standard procedures for cataract surgery 
and IOL implantation.  Key postoperative data collection includes monocular and 
binocular uncorrected and distance-corrected visual acuities, contrast sensitivity, 
defocus curve, slit-lamp findings, non-directed visual symptoms, questionnaires and 
adverse events.  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 bilateral cataract surgery with the second eye 
surgery occurring after the 1-week exam for the first eye but no more than 30 days 
after the first eye surgery.  After each surgery, the operative eye will be examined at 
1 day (1-2 days) and 1 week (7-14 days) postoperative.  Based on the date of the 
second-eye surgery, both eyes will be evaluated at 1 month (30-60 days) and 6 months 
(120-180 days) postoperative.  Unscheduled visits may be conducted as necessary at 
the discretion of the investigator for medically-indicated follow-up.   

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implanted, the subject may be scheduled for surgery and randomized to a treatment 
group.    
As the Informed Consent Form 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 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 DISTANCE VISUAL ACUITY AND MANIFEST REFRACTION  
Preoperative manifest refraction is required.  Monocular, best-corrected distance visual 
acuity (BCDVA) is to be measured using a standard Snellen chart or equivalent and 
must be Snellen 20/40 or worse with a glare source or 20/40 Snellen or worse without a 
glare source. 
KERATOMETRY  
Predicted postoperative corneal astigmatism, based on measurements by keratometry, 
should be less than 1.00 D.  No irregular astigmatism should be present preoperatively.  
If the preoperative keratometric astigmatism is greater than 0.50 D, assess the impact of 
posterior corneal astigmatism (PCA) on predicted residual astigmatism by using a 
calculator that accounts for PCA (e.g., J&J TECNIS Toric Calculator, Barrett Toric 
Calculator, etc.).  
CONTACT LENS WEAR AND CORNEAL STABILITY 
For contact lens wearers, keratometric corneal stability following cessation of contact 
lens wear must be verified before surgery.  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.  Corneal stability must be verified for any 
subject who has worn PMMA lenses within 5 years or any other type of contact lenses 
within 6 months prior to the preoperative visit.  To verify stability, repeat the keratometric 
measurements at least 1 week after the initial preoperative baseline keratometric 

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measurement.  Corneal curvature is considered to be stable if the difference in 
keratometric cylinder (vertical vs. horizontal keratometric readings) between the two 
timepoints does not exceed 0.50 D.  Additionally, the difference between the two 
horizontal readings as well as the difference between the two vertical readings must be 
no more than 0.50 D.  Changes in keratometric axis must be no more than ±15 ○.  If a 
change exceeding these criteria is noted, surgery is to be postponed until keratometric 
stability is demonstrated.  Final biometry measurements and surgery should not take 
place until keratometric stability is achieved.  Note: if this method of determining corneal 
stability is not a standard procedure in your practice, the subject must sign the informed 
consent form prior to starting the stability procedure.   
IOL POWER AND TARGETED REFRACTION  
Axial length and anterior chamber depth (ACD) must be measured to determine the 
appropriate lens power to implant using an A-Constant.  IOLMaster, Lenstar or 
immersion biometry methods are preferred; however, surgeons should use the biometry 
method with which they have the most experience and that which was used in the 
determination of personalized A-Constants for TECNIS IOLs.   
Power calculations for a given subject must be completed for both lens groups prior to 
randomization.  For investigational lens Model ZFR00V, IOL power should be 
determined with calculations using the labeled A-Constant of 119.3.  For control lens 
Model ZCB00, the investigator may use the labeled A-Constant of 119.3 or use their 
personalized A-Constant for the Model ZCB00 monofocal lens.   
Lens powers should be calculated to achieve emmetropia at distance in both eyes, and 
the IOL power that is predicted to result in the least amount of ametropia should be 
selected for implantation.  Intentional over- or under-correction should NOT be planned 
for either eye; however, surgeons may adjust the targeted refraction for the second eye 
only as necessary to achieve emmetropia based on a subject’s first-eye outcome.  
QUESTIONNAIRES 
Questionnaires will be administered preoperatively to collect information regarding 
spectacle usage, visual symptoms, visual quality, and subject satisfaction.  Two 
questionnaires will be used in this study:   
1) Patient-Reported Visual Symptoms Questionnaire (PRVSQ, Appendix M)  
2) Patient-Reported Spectacle Independence Questionnaire (PRSIQ, Appendix N) 
 
ADDITIONAL PREOPERATIVE INFORMATION TO BE COLLECTED: 
• 
Informed consent  
• 
Subject demographic information  

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• 
Planned surgery dates for each eye 
• 
Ocular history, including presence of ocular pathology for each eye  
• 
Intraocular pressure for each eye 
• 
Cataract type and density for each eye 
• 
Fundus exam results for each eye 
• 
Medical findings from a biomicroscopic slit-lamp exam for each eye 
• 
Ocular symptoms for each eye 
• 
Ocular and systemic medications 
 
10.4 
RANDOMIZATION AND STUDY MASKING 
A randomization list will be created by the J biostatistician for each investigative site and 
the randomization code will be uploaded into the electronic data capture system (EDC).  
Subjects will be randomized to the investigational lens Models ZFR00V and the control 
lens Model ZCB00.  Unmasked study personnel at the site will be trained to the 
randomization process through the EDC system and will randomize subjects after the 
subject has signed the informed consent form, has met all eligibility criteria and the 
investigator has documented which eye will be implanted first.  
For the duration of this study, the subjects and study staff who conduct study vision 
testing and/or collect study vision data will be masked to the treatment group to which a 
given subject was randomized.  For this reason, care must be taken such that subjects 
and masked evaluators are not informed of the implanted lenses.  In addition, key 
Sponsor personnel will be masked during the study, as necessary. 
As part of the informed consent process, the investigator or delegate will explain to the 
subject the requirements of a randomized study and the differences expected between 
the two lens models in the study: the investigational lens Model ZFR00V and the control 
lens Model ZCB00.  .   
Only the surgeon and the operative staff will know which lens type is implanted and will 
be unmasked throughout the study.  There may also be site coordinators and other site 
study staff, such as those performing slit-lamp exams, who will be unmasked.  
Unmasked study staff and study subjects will be instructed not to disclose the lens type 
the subject received or to talk about the lens to any subjects or masked evaluators. 
The subjects and the study technicians performing the postoperative vision tests are to 
be masked through study completion.  To maintain subject/technician-masking through 
the 6-month study exams, a masking plan will be tailored for each site to detail how lens 
assignment information will be concealed from masked technicians.  Recommended 
steps to maintain masking include ensuring that all items pertaining to lens group 
assignment and lens implantation records are kept separately from all other study 
documents and subject medical records until after completion of the final study visit.  For 

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example, lens stickers (indicating the lens model implanted) may be kept in the study 
product accountability notebook until completion of the final study visit, at which time 
they may be placed in the subject medical charts.  In the meantime, temporary lens 
stickers (without lens model designations) may be used in the subject’s medical chart.   
To maintain subject masking, a temporary IOL implant identification card will be issued 
to the subject at the time of surgery.  Following completion of the final study exam, each 
subject will be given the permanent IOL implant identification card. 
10.5 
STUDY LENS SUPPLY 
The investigational lenses will be obtained from a site consignment that is supplied by 
the Sponsor following IRB approval for a given site.  Two lenses should be available for 
each case, a primary lens and a back-up lens.  Unused back-up lenses are to be 
returned to the site consignment.  At the completion of study enrollment, any remaining 
consignment lenses will be shipped back to the Sponsor following reconciliation of 
investigational lens inventory by a Sponsor CRA.  At all times, the storage, access and 
use of all investigational lenses must be controlled and complete lens accountability 
maintained (See Section 15.2 Lens Accountability).   
Control lenses for the study will be sourced from each site’s routine commercial lens 
inventory or sponsor-provided consignment.   
10.6 
OPERATIVE PROCEDURES  
The investigator should use his or her standard, small-incision, cataract extraction 
surgical technique.  Lenses should be folded for implantation and inserted into the 
capsular bag using one of the Sponsor-validated insertion systems described in 
Section 7.2. 
Investigators should manage surgical outcomes to ensure that the total postoperative 
refractive astigmatism is as minimal as possible.  The total postoperative astigmatism, 
including surgically-induced astigmatism and PCA, should be targeted to be less than 
1.0 D.  Astigmatism may be managed by incision type and placement only.  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). 
Operative case report forms will include the following information: 
INCISION TYPE AND SIZE   
Lenses should be inserted through an incision ranging in size from approximately 
2.2-3.0 mm, per the investigator’s standard technique when using the UNFOLDER 
Platinum-1 Series Implantation System or the ONE SERIES Ultra Implantation System.  

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The incision may be clear corneal, limbal or scleral tunnel at the discretion of the 
investigator. 
CAPSULORHEXIS SIZE AND METHOD  
The anterior capsulotomy should be a continuous, curvilinear capsulorhexis 
approximately 5.0 to 5.5 mm in diameter to allow slight overlap of the lens optic edge.  
The anterior capsulotomy method may be manual (rhexis) or laser-assisted.  
CRYSTALLINE LENS REMOVAL 
Crystalline lens removal may occur using laser fragmentation combined with 
phacoemulsification/aspiration or using only phacoemulsification/aspiration.  
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) or the ONE SERIES Ultra Implantation 
System (DK7786 [plunger] or the DK7791 [twist] handpieces with the ONE SERIES Ultra 
cartridge, Model 1VIPR30).   
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, non-investigational 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 
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, 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 will be recorded on the CRF.   

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TYPE OF CLOSURE   
Wound closure is left to the surgeon’s discretion and will be recorded on the CRF. 
ADDITIONAL OPERATIVE INFORMATION COLLECTED INCLUDES: 
• 
Date of surgery 
• 
Operative eye 
• 
Lens model, power, and serial number 
• 
Lens placement 
• 
Other surgical procedures 
• 
Surgical technique according to protocol 
• 
Product complaints 
• 
Serious and/or device-related adverse events 
10.7 
POSTOPERATIVE PROCEDURES  
Postoperatively, subjects will be examined according to the schedule in Section 10.2, 
Visit Schedule.  Only the most recently operated eye will be evaluated at the subsequent 
1-day and 1-week visits after surgery.   
Both eyes will be evaluated at the 1-month and 6-month visits.   
Study technicians who are responsible for conducting all vision testing will be masked to 
study treatments.  Therefore, it is recommended that only the investigator/ 
sub-investigator or other designated and trained clinician perform the biomicroscopic slit-
lamp exams.  To maintain consistency and masking throughout the study, 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.  
NOTE:  Subjects are not to wear contact lenses postoperatively until after completion of 
this study.  Wearing contact lenses may potentially cause corneal edema or topography 
changes that may influence the visual acuity results.  During the study, if correction is 
required, spectacles should be prescribed.  
A CRF will be used to collect the following postoperative information, although not all 
data are required at every visit (see Appendix A): 
MANIFEST REFRACTION AND REFRACTION ADJUSTMENTS (MASKED 
PROCEDURE) 
Postoperative manifest refractions are to be performed using the M&S System at a 
distance of 4.0 meters.  Manifest refraction (MR) is to be performed using the Maximum 
Plus refraction method.  Autorefractors are not recommended for use in this study. 

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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 test distance 
and refraction distance.  Appendix C lists the refraction adjustments required for various 
vision tests that use the manifest refraction obtained from a distance of 4.0 meters 
(“ETDRS Rx”). 
DISTANCE VISUAL ACUITY TESTING (MASKED PROCEDURE) 
Distance visual acuity will be measured postoperatively under photopic lighting 
conditions (85 cd/m2, 80–110 cd/m2 acceptable) using the M&S System at a test 
distance of 4.0 meters.  For eyes unable to achieve a postoperative BCDVA of Snellen 
20/40 (i.e., LogMAR 0.3, number of letters correct 70), a reason must be specified.  
Instructions for using the M&S System are detailed in Appendix D, and for distance 
visual acuity testing in Appendix E.  
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
INTERMEDIATE VISUAL ACUITY (MASKED PROCEDURE) 
Intermediate visual acuity will be measured under photopic conditions (85 cd/m2, 
80-110 cd/m2 acceptable) using the M&S System at a test distance of 66 cm.  
Instructions for using the M&S System are detailed in Appendix D and for intermediate 
vision testing in Appendix F.   

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NEAR VISUAL ACUITY (MASKED PROCEDURE) 
Near visual acuity will be measured at test distances of 40 cm and 33 cm under photopic 
conditions (85 cd/m2, 80-110 cd/m2 acceptable) and at 40 cm under mesopic conditions 
(3 cd/m2) using the M&S System.   
Instructions for using the M&S System are detailed in Appendix D and for near vision 
testing in Appendix G.   
The following near visual acuity measurements are to be performed per the visit 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
  
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
DEFOCUS TESTING (MASKED PROCEDURE) 
Binocular and monocular (first eye) best-corrected distance defocus testing will be 
performed on all subjects in accordance with the methodology described in Annex F of 
the International Standards for Ophthalmic Implants – Intraocular Lenses Part 7 
(ISO 11979-7:2018).  While the testing includes plus-power defocus, the study endpoint 
is based upon minus-power defocus results. 
Defocus testing will be performed under photopic conditions (85 cd/m2, 80-110 cd/m2 is 
acceptable) using the M&S System at 4.0 meters with the ETDRS refraction in place (no 
adjustment necessary for test distance).  
 

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At each defocus increment, a LogMAR visual acuity is to be obtained.  Further 
instructions for defocus testing are detailed in Appendix H. 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
  
 
PUPIL SIZE  
Pupil sizes under photopic (with and without glare), and mesopic (with and without glare) 
lighting conditions will be measured postoperatively during the study.  For consistency, 
the same method of measurement should be used throughout the study. 
Photopic pupil size measurements are to be performed under the same lighting 
conditions at which photopic distance visual acuity is tested.  Pupil sizes under the other 
lighting conditions will be measured during the contrast sensitivity testing procedures.  
Instructions for measuring pupil size are detailed in Appendix J.  
DISTANCE CONTRAST SENSITIVITY TESTING (MASKED PROCEDURE) 
Best-corrected distance contrast sensitivity will be tested monocularly (first eye) and 
binocularly under mesopic with and without glare and photopic with glare conditions 
using the M&S System for sine-wave gratings at 1.5, 3, 6, and 12 cycles per degree 
(cpd) (mesopic without glare and mesopic with glare) and 3, 6, 12, and 18 cpd (photopic 
with glare).  The test distance is 8 feet (2.5 meters).  Best-corrected distance contrast 
sensitivity is to be performed with a +0.12 D refraction adjustment, added to the sphere 
of the manifest refraction.  Detailed instructions for contrast sensitivity testing are 
provided in Appendix K.  

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BIOMICROSCOPIC SLIT-LAMP EXAM   
A biomicroscopic slit-lamp exam must be performed at each postoperative visit to 
determine the presence or absence of any medical or lens findings, complications or 
adverse events.  IOL decentration and tilt are to be determined subjectively.  The center 
of the lens relative to the pupil can be used to determine IOL decentration, and, if 
present, the diffractive rings may be used as a guide to locate the center of the IOL.  
Note that the pupil center may not always be aligned with the visual axis of the eye; 
therefore, the investigator should consider deviations in pupil center from visual axis 
when reporting IOL decentration.   
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 L.   
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 
6-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 6-month visit to evaluate retinal status and 
fundus visualization.  Examinations may be done dilated with ophthalmoscopy or 
undilated with an imaging system that allows for undilated views of the peripheral retina 
(e.g., Optomap).  The same fundus examination method that was used preoperatively 
should be used for the 6-month study visit. 

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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 a subject reports halos, glare or starbursts, the level 
of severity should be determined (mild, moderate or severe). 
MEDICATIONS   
Postoperative ocular medications should be used as is customary for each investigator 
and recorded in the source document for each subject.  Medications will be recorded on 
a medication log CRF as applicable. 
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, for further information. 
QUESTIONNAIRES  
Questionnaires will be administered at the 1-month and 6-month visits to collect 
information regarding spectacle usage, visual symptoms, visual quality, and subject 
satisfaction.  Two questionnaires will be used in this study:   
1) 
Patient-Reported Visual Symptoms Questionnaire (PRVSQ, Appendix M)  
2) 
Patient-Reported Spectacle Independence Questionnaire (PRSIQ, Appendix N) 
In order to minimize any effect the doctor-patient relationship may have on a subject’s 
responses on the questionnaire, the study questionnaires will be self -administered by 
the subjects.  The questionnaires are to be administered at the start of the 1-month and 
6-month study visits, prior to any visual acuity testing. 
In addition, if a subject is seen after the 1-month postoperative visit for an unscheduled 
visit due to an optical/visual symptom complaint, the PRVSQ will be administered at that 
visit, as well as prior to any secondary surgical intervention for an optical/visual symptom 
complaint.  If additional unscheduled visits and/or a secondary surgical intervention due 
to the same optical/visual symptom complaint occur within 2 weeks of each other, it is 
not necessary to complete the PRVSQ a second time. 
The optical visual symptom complaints that trigger the need for the PRVSQ to be 
administered at an unscheduled visit include any of the seven symptoms from the 

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PRVSQ: halos, glare, starbursts, sensitivity to light, occlusions, multiple or double vision 
or poor low light vision. 
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 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 randomization or surgery, implantation in the first 
eye is aborted due to a surgical complication, or the subject dies prior to first-eye 
treatment.   
Subjects will be "discontinued" from the study if the subject is randomized but does not 
undergo surgery; or if one study lens (if implanted unilaterally) or both study lenses (if 
implanted bilaterally) 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.   

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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: 
• Snellen manifest refraction 
• Uncorrected and best-corrected distance visual acuity using a Snellen chart 
• Intraocular pressure 
• Slit-lamp examination for medical and/or lens findings  
• Fundus exam 
• Ocular symptoms 
• Adverse events 
• Medications 
If, prior to the second-eye surgery, the fellow eye is re-examined (e.g., at a first eye,  
1-day visit) and there are clinically significant changes from the preoperative exam, data 
are to be reported using the Unscheduled Visit CRF.  If there are no changes or 
non-clinically significant changes from the original preoperative exam, an Unscheduled 
Visit CRF is not required. 
At a second-eye 1-day or 1-week visit (or a 1-month visit, if the visit intervals for the first 
and second eyes do not overlap), if the first eye is examined and there are medical 
and/or lens findings and/or a subject has an optical/visual symptom complaint, data are 
to be reported using the Unscheduled Visit CRF.  
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. 
In addition, if a subject is seen after the 1-month postoperative visit for an unscheduled 
visit due to an optical/visual symptom complaint, the PRVSQ must be administered, a 
mesopic pupil size measurement obtained, and monocular contrast sensitivity under 
mesopic (with and without glare) conditions at that visit.  These must be done prior to 
any secondary surgical intervention for an optical/visual symptom complaint.  If 
additional unscheduled visits and/or a secondary surgical intervention due to the same 
optical/visual symptom complaint occur within 2 weeks of each other, it is not necessary 
to complete the PRVSQ, mesopic pupil size, or monocular contrast sensitivity 
measurements a second time. 

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The optical visual symptoms that, when reported at an unscheduled visit, trigger the 
need for PRVSQ administration include any of the seven symptoms listed in the PRVSQ: 
halos, glare, starbursts, sensitivity to light, occlusions, multiple or double vision or poor 
low light vision.  
 
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 using the protocol 
deviation CRF.  Any deviation made to protect the life or physical well-being of a subject 
in an emergency as well as any use of the investigational device without obtaining 
informed consent 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 or not 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 
• 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 

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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 O. 
• 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) 
• 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 O (i.e., corneal edema resulting in 
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months).  Raised IOP, according to the guidelines listed in Appendix O will be 
considered serious if present at the last study visit (120-180 days after second eye 
implant). 
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 as well as the investigational device.  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 or not 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.   
Reporting of adverse events shall follow the USA Code of Federal Regulations (21CFR 
812) for sites in the USA.  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.  

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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.   
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 

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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 

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by the FDA and all other appropriate regulatory agencies, as well as approval of the 
governing IRBs prior to implementation.   
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, informed consent forms 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 informed consent form must be signed by 
each study subject prior to any study-specific examinations being performed.  The 
IRB-approved informed consent form is to be signed and dated by the subject as well as 
by the person who conducted the informed consent discussion.  The signed informed 
consent form 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 

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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: 
• 
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 (NOTE: This is masked information, and may 
only be reviewed by unmasked study staff) 
• 
Concurrent medications 
• 
Corrected and uncorrected distance visual acuity (NOTE: M&S electronic data are 
considered source documentation and are to be retained by the site.  A paper copy 
of the M&S results will be printed and validated by the site) 
• 
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.  

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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 
investigation, as directed by the Sponsor.  
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. 

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Device Accountability 
Complete accountability of the investigational lenses will be maintained at the 
investigative site by maintaining records of all study lenses (Model ZFR00V) received 
from and returned to the Sponsor.  A site log will be used to track all investigational 
lenses for date of receipt, eye implanted, serial number, lens power, use and 
disposition/return to the Sponsor; in addition, serial numbers will be recorded for all 
implanted control lenses.  This site log and any other study lens information will be 
maintained in the operating room study binder.  During periodic investigative site 
monitoring visits, Sponsor personnel will review site lens inventory records and logs to 
ensure IOL accountability compliance and investigational lens traceability.   
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.  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 and conformance to lighting levels for visual 
acuity tests will be verified.   
Additional training on study-specific procedures may also be conducted during 
monitoring visits.  A training/monitoring visit specific to this study is likely to occur just 
prior to or during the first of the 1-month and 6-month visits, wherein the most extensive 
vision testing occurs.  
Upon study completion, a site visit will be made to each site to monitor the last of the 
subject data records and finalize any outstanding study issues.  

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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.  
15.3 
SAFETY 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 any interim progress reports, as applicable.   
16. 
PUBLICATIONS 
Refer to the Clinical Trial Agreement for information regarding JJSV publication policies. 
17. 
RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
Investigational IOL Model ZFR00V 
The investigational IOL Model ZFR00V is designed to provide far vision and a range of 
intermediate to near vision; however, glasses may still be needed to improve distance 
vision and/or to have better vision for certain intermediate or near tasks.  Some visual 
symptoms, particularly dysphotopsias such as halos, glare, starbursts, etc., may be 
expected.  Dysphotopsias may become less noticeable over time; however, the IOL may 
be removed if necessary.  There may be a reduction in contrast sensitivity under certain 
conditions compared to a monofocal lens although contrast sensitivity is expected to be 
similar to that of TECNIS Multifocal IOLs.  Due to the diffractive optic design, the ability 
to perform some eye treatments (e.g., retinal photocoagulation) may be affected, and 
caution should be used when interpreting results of autorefractors or wavefront 
aberrometers that utilize infrared light, or when performing a duochrome test.  These 
risks are not unlike those for other diffractive technology IOLs, but the use of these 
instruments is not recommended for use in this study.   
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.   

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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 the 
Sponsor according to Section 11.0, Adverse Events and Product Complaints.  
Additionally, the Sponsor 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 investigational IOL Model ZFR00V is expected to 
be similar to the TECNIS Model ZCB00 IOL regarding distance visual acuity and safety 
outcomes.  Improved vision in the intermediate to near range, as well as functionality for 
certain tasks, may be achieved with the investigational IOL Model ZFR00V compared to 
the control IOL. 
CONCLUSION 
The hazards/risks associated with the investigational IOL Model ZFR00V are acceptable 
and within the range of those of other advanced-optic IOLs from JJV.  The potential 
clinical benefits of the investigational IOL Model ZFR00V outweigh the residual risks 
when the device is used as intended.  
18. 
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 25 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. 
• 
All case report forms  
• 
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) 
• 
Investigational supply records/inventory 
• 
IRB approval documentation 

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• 
Study correspondence  
• 
Study agreements 
• 
Site visit documentation 
• 
Protocol(s) 
• 
Subject log(s) 
• 
Clinical Investigator’s Brochure 
• 
Completed subject informed consent forms and medical privacy forms (e.g., 
Authorization for Use/Disclosure of Health information) 
• 
Subject medical chart/clinic notes (Not applicable for transfer of ownership to the 
Sponsor) 
19. 
TERMINATION OF THE INVESTIGATION 
The clinical investigation will be suspended in the event of high levels of complications 
and/or adverse events that are unexpected in nature and/or severity and evaluated as to 
causality relative to the study device.  The clinical investigation may be suspended if the 
Medical Monitor or the IRB, upon review and evaluation of the clinical data, finds 
unacceptable clinical performance or the level of single or total complications and/or 
adverse events unacceptable for continuation of the investigation. 
If causality is shown not to be related to the study device, the study may be resumed in 
accordance with the IRB and regulations of the FDA.  The study will be terminated if 
causality is shown to be related to the study device. 
Additionally, the investigator or the Sponsor may stop a subject’s participation at any 
time.  The Sponsor may also stop the study at any time for reasons it determines 
appropriate.  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. 
20. 
STATISTICAL METHODS 
This section highlights the analyses to be performed for key study endpoints.  The key 
study timeframe for all endpoints will be the 6-month postoperative visit;  however, data 
will be reviewed at other time points as well.  
20.1 
ANALYSIS POPULATION 
For the primary effectiveness endpoint (DCNVA at 40 cm) and monocular secondary 
effectiveness endpoints (DCIVA, DCNVA (at 33 cm) and BCDVA), 
 
 
 

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For eyes that do not have data available at the 6-month postoperative visit, data will be 
imputed for the mITT population analyses. For continuous variables (DCNVA, BCDVA 
and DCIVA), planned method to use is the MCMC full-data imputation as described in 
Little & Rubin3 . 
 
 
 
  
 
 
 
 
  
 
 
 
   
 
 
 
 
     
 
 
3 Little, R. and Rubin, D. Statistical Analysis with Missing Data, John Wiley & Sons, Inc. New York, Second 
Edition, (2002). 
4 SAS Institute. The MI and MIANALYZE Procedures. SAS/STAT 9.2 User Guide. and SAS/STAT User 
Guide for the MI Procedure: Imputation Methods. Cary, N.C. 

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A Per-Protocol (PP) analysis will also be used for primary effectiveness and secondary 
endpoints. The PP population for monocular data will include eyes with a test or control 
lens implanted, evaluated within the proper study interval and without clinically-relevant 
protocol deviations (deviations that could potentially impact the primary or secondary 
endpoints) as determined prior to database lock. The PP population for binocular data 
will include subjects that do not have any of the deviations stated above in either eye.  
PP tables will include available data at the time of analysis.   
The safety population (SP) will consist of all eyes and subjects implanted with either a 
test or control IOL(s) and with data available at the time of analysis (i.e., no data 
imputation).  Reporting of cumulative complications and adverse events (occurring at 
any time postoperative) will include data from all study eyes implanted. For all safety 
endpoints and other endpoints, only safety population will be used. For BCDVA percent 
20/40 or better vs. ISO SPE rate, a best-case population will also be used, consisting of 
eyes in the safety population without any clinically-relevant preoperative ocular 
pathologies or macular degeneration detected at any time.  
For the primary DCNVA (at 40 cm), secondary BCDVA, DCIVA, DCNVA (at 33 cm) and 
spectacle wear endpoints, the mITT, sensitivity, PP and safety populations will be used 
for data reporting.   For defocus curve secondary endpoint, only safety and PP 
populations will be used for data reporting.  For safety endpoints and other endpoints, 
only the safety population will be used. The primary analysis will be based on first eye 
data, unless stated otherwise. However, select data such as some visual acuity 
variables will also be reported separately for second eyes as supportive data only. 
Safety (adverse events, medical and lens findings, and non-directed visual symptoms) 
and effectiveness endpoints (monocular DCNVA (at 40 and 33 cm), BCDVA and DCIVA) 
and monocular mesopic DCNVA will also be evaluated using all eyes (pooling both first 
and second eyes together) as supportive analysis.  Descriptive statistics will be 
presented for analyses of all eyes. 
 
 
 
 
 
 
 
 
 
 
 

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5 Rom D and B. Holland. (1995). A new closed multiple testing procedure for hierarchical families of 
hypotheses. Journal of Statistical Planning and Inference 46:265-275   
6 Rom D, R. Costello, and L. Connell. (1994). On closed test procedures for dose-response analysis. 
Statistics in Medicine 13:1583-1596   
7 Marcus R, E. Peritz, and K. Gabriel. (1976). On closed testing procedures with special reference to ordered 
analysis of variance. Biometrika 63:655-660.   
8 Huque M and A Sankoh. (1997). A reviewer’s perspective on multiple endpoint issues in clinical trials. 
Journal of Pharmaceutical Sciences 7:545-564. 

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20.4 
SITE POOLABILITY ANALYSIS 
For the primary effectiveness and secondary effectiveness endpoints, data will be 
reported by site. 
 
 
 
 
 
. Since there are no inferential statistics for the 
secondary defocus curve endpoint, only graphs (defocus curve by site) will be presented 
for the site analysis.  Baseline demographic data will also be reported by site.   
20.5 
VISUAL ACUITY CONVENTIONS AND GENERAL STATISTICS  
Visual acuity data will be converted to LogMAR values prior to analysis and adjusted for 
the test distance used if it is not the standard distance for the chart.  Descriptive 
statistics will typically include sample size (N), mean, standard deviation (SD), median, 
minimum (Min) and maximum (Max) as appropriate for continuous variables.  For 
continuous variables, statistical tests (e.g., t-test) assuming normality will generally be 
used.  For categorical data, the frequency and proportion will be reported, and Fisher’s 
exact test or Chi-square test will generally be applied.  For ordinal categorical data, the 
frequency and proportion will be reported with the Wilcoxon Rank-Sum test generally 
used.   

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20.6 
INTERIM REPORTS 
No interim study progress reports will be conducted for this study. 
20.7 
SAMPLE SIZE CALCULATIONS 
Study sample sizes are based on the requirements for a Level B modification of a parent 
lens as well as the requirement for contrast sensitivity testing.  The minimum 
requirements are 100 evaluable test subjects per lens group for Level B and 122 
evaluable test subjects per lens group for contrast sensitivity.  The screen failure rate is 
assumed at 10%, and the dropout rate is assumed at 10%.  To achieve approximately 
122 evaluable subjects in each IOL group at 6 months postoperative and allowing for 
screen failures and drop out, 150 subjects will be enrolled in each lens group to achieve 
approximately 135 bilaterally implanted subjects in each lens group.   
 
1.   Monocular, Distance-corrected Near Visual Acuity (DCNVA) at 40 cm 
For monocular (first eye), distance-corrected near visual acuity (DCNVA), there is over 
90% power to detect a 0.7-line or greater difference in mean visual acuity between the 
test and control groups (assumes one-sided testing with an alpha of 0.025 and standard 
deviation of 1.6 lines) with 122 subjects in each lens group. 
 
2. Monocular, Best-corrected Distance Visual Acuity (BCDVA) 
For monocular (first eye), best-corrected distance visual acuity (BCDVA), there is over 
90% power to detect a 1-line or greater difference in mean visual acuity between the test 
and control groups (assumes one-sided testing with an alpha of 0.025 and standard 
deviation of 1.2 lines) with 122 subjects in each lens group. 
 
3. Spectacle Wear 
For spectacle wear, there is more than 90% power to detect a 20% difference between 
test and control subjects (assumes 80% for test and 60% for control, using a one-sided 
Fisher’s Exact test with an alpha of 0.025) with 122 subjects in each lens group.   
4. Monocular Defocus Curve 
There is no statistical comparison for this endpoint; therefore, no sample size calculation 
is performed for this endpoint. 
 
5. Monocular, Distance-corrected Intermediate Visual Acuity (DCIVA) 
For monocular (first eye), distance-corrected intermediate visual acuity (DCIVA), there is 
over 90% power to detect a 0.7-line or greater difference in mean visual acuity between 
the test and control groups (assumes one-sided testing with an alpha of 0.025 and 
standard deviation of 1.6 lines) with 122 subjects in each lens group. 
 
6. Monocular, Distance-corrected Near Visual Acuity (DCNVA) at 33 CM 
For monocular, distance-corrected near visual acuity (DCNVA) at 33 cm, there is over 
90% power to detect a 0.7-line or greater difference in mean visual acuity between the 

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test and control groups (assumes one-sided testing with an alpha of 0.025 and standard 
deviation of 1.6 lines) with 122 subjects in each lens group. 
 
7. Monocular and Binocular Contrast Sensitivity 
For contrast sensitivity, the ISO 11979-7:2018 sample size criteria for contrast sensitivity 
analysis are met with 122 subjects in each lens group.