Clinical Investigation of the Next Generation Phaco System (VERITAS Vision System)
Phase: NA
Conditions: Cataract
Sponsor: Johnson & Johnson Surgical Vision, Inc.

Study Protocol 
Clinical Investigation of the 
Next Generation Phaco System (VERITAS 
Vision System) 
NCT Number: NCT04332640 
Document date: 17 Jun 2020 

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CONFIDENTIAL 
The following contains confidential, proprietary information 
that is the property of Johnson & Johnson Surgical Vision 
Clinical Investigation of the 
Next Generation Phaco System (VERITASTM Vision System) 
PROTOCOL NUMBER:  ALPI-101-SYST 
EUDAMED number: TBD 
SPONSOR:  Johnson & Johnson Surgical Vision, Inc. 
  1700 E. St. 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 and all
other applicable FDA regulations; conditions of approval imposed by the
reviewing Institutional Review Board (IRB) or Independent Ethics Committee
(IEC), 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/IEC 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 
Acknowledged By: 
Signature of Sponsor’s Representative 
Date 
________________________________________________________________ 

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TABLE OF CONTENTS 
TABLE OF CONTENTS ...................................................................................................... 2 
PROTOCOL CHANGE HISTORY ...................................................................................... 5 
1. 
SYNOPSIS .............................................................................................................. 6 
2. 
BACKGROUND/INTRODUCTION ....................................................................... 10 
3. 
CLINICAL HYPOTHESIS ..................................................................................... 10 
4. 
STUDY DESIGN ................................................................................................... 10 
5. 
ACRONYMS ..........................................................................................................11 
6. 
STUDY OBJECTIVES AND ENDPOINTS ............................................................11 
6.1 
ENDPOINTS ..........................................................................................................11 
7. 
STUDY PRODUCTS ............................................................................................ 12 
8. 
STUDY POPULATION ......................................................................................... 13 
9. 
INVESTIGATOR SELECTION ............................................................................. 14 
9.1 
INVESTIGATOR QUALIFICATIONS .................................................................... 14 
9.2 
INVESTIGATOR OBLIGATIONS ......................................................................... 14 
9.3 
INVESTIGATOR APPROVAL .............................................................................. 15 
9.4 
INVESTIGATOR INFORMATION ......................................................................... 16 
10. 
EXPERIMENTAL PLAN ........................................................................................ 16 
10.1 
OVERVIEW ........................................................................................................... 16 
10.2 
VISIT SCHEDULE ................................................................................................ 17 
10.3 
PROCEDURES ..................................................................................................... 17 
10.4 
VERITASTM VISION SYSTEM SUPPLY .............................................................. 22 
10.5 
EXIT OF SUBJECTS ............................................................................................ 22 
10.6 
UNSCHEDULED VISITS ...................................................................................... 22 
10.7 
PROTOCOL DEVIATIONS ................................................................................... 23 
11. 
ADVERSE EVENTS AND PRODUCT COMPLAINTS ......................................... 23 
11.1 
DEFINITIONS ....................................................................................................... 23 
11.2 
PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION .......................... 25 
11.3 
ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS ........... 25 
11.4 
CAUSAL RELATIONSHIP .................................................................................... 26 
11.5 
ADVERSE EVENT FOLLOW-UP ......................................................................... 27 
12. 
PROTOCOL CHANGES/AMENDMENTS ............................................................ 27 
13. 
ETHICS REVIEW AND SUBJECT WELFARE .................................................... 27 

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13.1 
INDEPENDENT ETHICS COMMITTEE (IEC) OR INSTITUTIONAL REVIEW 
BOARD (IRB) ........................................................................................................ 27 
13.2 
INFORMED CONSENT ........................................................................................ 28 
14. 
DOCUMENTATION .............................................................................................. 28 
14.1 
SOURCE DOCUMENTS ...................................................................................... 28 
14.2 
SUBJECT CONFIDENTIALITY ............................................................................ 29 
14.3 
CASE REPORT FORM COMPLETION ............................................................... 29 
14.4 
STUDY SUMMARY .............................................................................................. 29 
15. 
MONITORING ....................................................................................................... 29 
15.1 
DATA MONITORING ............................................................................................ 29 
15.2 
ADMINISTRATIVE MONITORING ....................................................................... 30 
15.3 
SAFETY MONITORING ....................................................................................... 31 
16. 
PUBLICATIONS .................................................................................................... 31 
17. 
RISK ANALYSIS ................................................................................................... 31 
18. 
RECORDS RETENTION ...................................................................................... 32 
19. 
TERMINATION OF THE INVESTIGATION ......................................................... 33 
20. 
STATISTICAL METHODS .................................................................................... 33 
20.1 
ANALYSIS POPULATION .................................................................................... 33 
20.2 
STUDY ENDPOINTS ............................................................................................ 33 
20.3 
SAMPLE SIZE CALCULATIONS ......................................................................... 34 
APPENDIX A. SUMMARY OF PROCEDURES REQUIRED .......................................... 36 
APPENDIX B.  EQUIPMENT LIST ................................................................................... 37 
APPENDIX C. SLIT-LAMP EXAM RATINGS ................................................................... 38 
APPENDIX D. NEXT GENERATION PHACO SYSTEM (VERITASTM VISION SYSTEM) 
PERFORMANCE RATING QUESTIONNAIRE .................................................... 41 
APPENDIX E. ADVERSE EVENT AND COMPLAINT REPORTING INSTRUCTIONS . 45 
APPENDIX F. LIST OF POTENTIAL PRINCIPAL INVESTIGATORS AND SUB-
INVESTIGATORS  ................................................................................................ 46 
 
 
 
 
 
 
 

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PERSONNEL AND FACILITIES  
 
SPONSOR: 
Johnson & Johnson Surgical Vision, Inc.  
 
1700 East Saint Andrew Place 
 
Santa Ana, CA 92705 
 
SPONSOR PERSONNEL: 
 
 
Medical Monitor: 
 
Sr. Medical Director, External Innovation and Medical 
Science Strategy 
 
Office:  
 
 
Medical Safety Officer:                
 
Medical Safety Officer 
 
Office:  
  
 
Director, Clinical Science: 
 
 
Director, Clinical Science 
 
Office:  
 
 
Clinical Research Scientist: 
 
 
 
Principal Clinical Research Scientist 
 
Office: 
 
 
Sr. Manager, Clinical Operations: 
 
 
Sr. Manager, Clinical Operations 
 
Office:  
 
 
Study Manager: 
 
 
Manager, Clinical Research 
 
Office:
 
 
Lead Clinical Research Associate: 
 
 
Lead Clinical Research Associate 
 
Office:
 
 
 
 
Biostatisticians: 
 
 
Principal Biostatistician 
 
Office:  
 
 
 
 
EMERGENCY TELEPHONE NUMBERS: 
      
Office: 
 
Cell: 
 
  

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PROTOCOL CHANGE HISTORY 
Version 
Section(s) 
Page(s) 
Description of Change(s)  
Rationale for Change(s) 
1.0 
N/A 
N/A 
Original 
N/A 
2.0 
1) 1 and 4 
 
2) 11 
 
 
 
 
3) Appendix 
D 
 
 
 
 
4) 1, 4, and 
20 
1) 6 and 10 
 
2) 24-25 
 
 
 
3) 41-44 
 
 
 
 
4) 6, 10, 
and 34-35 
1) Removed restriction of 
OUS sites. 
2) Added description of 
Study-Specific Anticipated 
Adverse Events and 
updated the list of Study-
Specific Anticipated 
Adverse Events in section 
11. 
3) Refined Appendix D 
“Next Generation Phaco 
System Performance 
Rating Questionnaire” and 
re-structured it into two 
parts (operative and post-
operative). 
4) Modified the sample size 
to reflect the updated study 
strategy. 
1) 
Provide more flexibility in 
site selection. 
2) 
Update the list of Study-
Specific Anticipated Adverse 
Events and the list of Study-
Specific Serious Anticipated 
Adverse Events. 
 
3) 
Make the questionnaire easy 
to fill out. 
 
 
 
 
4) 
Update the sample size to 
collect more feedbacks from 
surgeons on the VERITAS 
Vision System. 

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1. 
SYNOPSIS 
PROTOCOL: 
Clinical Evaluation of the Next Generation Phaco System 
(VERITASTM Vision System) 
Protocol Number:  APLI-101-SYST 
 
STUDY TREATMENTS: 
Investigational Product: The VERITASTM Vision System. 
The product families include: 
 
• 
VERITASTM REMOTE CONTROL 
• 
VERITASTM CONSOLE 
• 
VERITASTM FOOTPEDAL 
• 
VERITASTM SWIVEL HANDPIECE  
• 
ADVANCED FLUIDICS PACK 
• 
ADVANCED INFUSION PACK 
 
STUDY OBJECTIVE: 
The purpose of this study is to evaluate the overall clinical 
performance of the VERITASTM Vision System in human 
subjects and to confirm the overall surgeon acceptability.   
 
CLINICAL HYPOTHESIS: 
The VERITASTM Vision System will achieve favorable 
surgeon acceptance and clinical performance. 
 
OVERALL STUDY DESIGN: 
Structure: 
Prospective, open-label clinical study.  
 
Number of sites: 
Up to 3 sites. 
 
Duration: 
There will be 3 scheduled visits: A Pre-Operative visit, an 
Operation visit (may happen on the same day as 
preoperative visit), and a 1-Day Post-Operative visit. 
 
Administration: 
The investigators or designees will perform routine small-
incision cataract surgery via phacoemulsification and use 
the VERITASTM Vision system. The Investigator or 
designee will then complete a questionnaire regarding the 
clinical use of the VERITASTM Vision system. The system 
log files automatically generated by the VERITASTM Vision 
system after completion of each surgery will be collected. 
 
Visit Schedule: 
Each subject will undergo 3 visits: Preoperative for both 
eyes (including informed consent, screening for study 
participation), Operative and 1-Day Post-Op for one eye.  
A questionnaire will be completed by the investigator or 

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designee.  A typical pre-treatment visit will be 
approximately 60-120 minutes long, a typical operation 
visit will take 30-60 minutes, and a typical 1-Day post-op 
visit will take another 10-20 minutes. 
 
STUDY POPULATION CHARACTERISTICS: 
 
Condition: 
Presence of cataract for which phacoemulsification 
extraction is indicated in at least one eye. 
 
Number of Subjects: 
Minimum 55 eyes and up to 150 eyes will be treated.  
Inclusion Criteria (all criteria apply to each study eye): 
• 
Minimum 22 years of age.  
• 
Cataracts for which cataract extraction and posterior chamber IOL implantation 
have been planned.  
• 
Availability, willingness, ability and sufficient cognitive awareness to comply with 
study requirements, examination procedures, and visits. 
• 
Be willing to provide informed consent and authorization to disclose protected 
health information or equivalent documentation necessary to comply with 
applicable privacy laws pertaining to medical procedures in the governing 
countries. 
 
Exclusion Criteria (all criteria apply to each study eye): 
• 
Expected surgical difficulties at the time of cataract extraction, which may 
increase the potential for complications (e.g., persistent bleeding, significant iris 
damage, uncontrolled intraocular pressure change, or significant vitreous 
prolapse or loss).  
• 
Subjects with only one good eye (e.g. amblyopic condition etc.).  
• 
Subjects with conditions associated with increased risk of zonular rupture, 
including capsular or zonular abnormalities that may lead to IOL decentration, 
including pseudoexfoliation, trauma, or posterior capsule defects.  
• 
History or current use of alpha-1 antagonist medication (e.g., Flomax).  
• 
Any condition which, in the Investigator's opinion, would make it unsafe (for the 
subject or for the study personnel) to treat the subject as part of this research 
study or for which cataract surgery is contraindicated.  
• 
Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils).  
• 
Is pregnant, or is breast feeding, or intend to become pregnant during the study. 
• 
Concurrent participation or expected participation in an interventional (i.e., 
surgical or pharmaceutical interventional) clinical trial within 14 days prior to 
study screening. 
 
 

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STUDY ENDPOINTS: 
 
Primary Endpoints: 
➢ Overall clinical performance will be evaluated based on surgeon’s ratings, 
system log files, operative report and other medical records for the following 
items: 
o Rating of anterior chamber stability 
o Rating of followability  
o Rating of holdability  
o Rating of Phaco (cutting) efficiency 
o Satisfaction with usability of VERITASTM Vision System 
o Overall satisfaction with VERITASTM Vision System  
Note: Surgeon rating will be on a scale from 1 to 5, defined as 1 – unsatisfied, 2- 
somewhat unsatisfied, 3 – neither satisfied nor unsatisfied, 4 – satisfied and 5 – 
very satisfied. Surgeon acceptability will be considered favorable for scores of 4 
and 5.  
Other Endpoints: 
➢ Effective Phaco Time (EPT)  
➢ Ultrasonic Time (UST) 
➢ Average Phaco Power (AVG) 
➢ Volume of balanced salt solution (BSS) used 
➢ Satisfaction with VERITASTM Footpedal 
➢ Satisfaction with VERITASTM Swivel Handpiece 
➢ Rating of corneal clarity at 1-day post-op 
➢ Satisfaction with 1-day post-op clinical results of surgery with VERITASTM Vision 
System 
➢ Rate of adverse events and complications. 
Note: Other endpoints will be collected from surgeon’s ratings, system log files, 
operative report and other medical records. 
 
 

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STUDY VISITS AND PROCEDURES: 
Inclusion and exclusion qualifications will be assessed at the preoperative visit according 
to the inclusion/exclusion criteria.  The Informed Consent Document and Authorization 
for Use/Disclosure of Health Information form (HIPAA authorization or equivalent 
documentation necessary to comply with applicable privacy laws pertaining to medical 
treatment in the governing countries) must be signed by any subjects who agree to 
participate in the study prior to undergoing any study-specific procedures. The subjects 
are considered enrolled upon signing and dating the Informed Consent Form. After 
determination that all inclusion/exclusion criteria have been met, enrolled subjects will 
undergo cataract surgery with the VERITAS Vision System. Following the procedure, the 
investigator or designee will complete a questionnaire regarding the clinical use of the 
VERITASTM Vision System for each case (Appendix D).  
Key data collection includes system settings, surgeons’ subjective rating on various 
aspects of the surgeries, medical complications, ocular/visual symptoms, and adverse 
events during the study. 
A chart summary of procedures required at each visit is provided in Appendix A. 
DATA ANALYSIS: 
Clinical performance will be considered favorable for rating scores of 4 (satisfied) and 
above (based on a 1 [unsatisfied] – 5 [very satisfied] scale). Surgeon rating scores will 
be presented as proportion with associated confidence interval for scores of 4 and above 
for each item in the surgeon questionnaires (Appendix D). 
Sample Size Calculation:  
Minimum 55 eyes and up to 150 eyes will be treated to gain further surgeon experience 
with the new system. 
A two-sided 95% confidence interval for an expected proportion of 0.95 using the large 
sample normal approximation will extend 0.058 (i.e., the precision of 5.8%) with a 
sample size of 55 eyes and will extend 0.035 (i.e., the precision of 3.5%) with a sample 
size of 150 eyes. 

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2. 
BACKGROUND/INTRODUCTION 
Phacoemulsification, using ultrasound energy, has evolved to be the most efficient 
method for cataract extraction and cataract surgery. The current trend for 
phacoemulsification includes smaller incision size, higher vacuum level usage, as well 
as continuously evolving techniques for lowering ultrasound energy and more efficient 
cataract removal.    
The VERITASTM Vision System is a next generation Phacoemulsification (Phaco) system 
from Johnson & Johnson Surgical Vision (JJSV).  It aspirates the emulsified lens out of 
the chamber, and provides irrigation to help maintain the depth and pressure of the 
chamber. The VERITASTM Vision system sub-modes allow the surgeon to also perform 
Diathermy (electrical cauterization) and Vitrectomy (a cutting action). 
3. 
CLINICAL HYPOTHESIS 
The VERITASTM Vision System will achieve favorable surgeon acceptance and clinical 
performance based on their responses to the key clinical performance questions listed in 
Appendix D. 
4. 
STUDY DESIGN 
This study is a prospective, open-label clinical study of the VERITASTM Vision System.  
The study will be conducted at up to three sites, with minimum 55 eyes and up to 150 
eyes to be treated.  The investigator or designee will perform the cataract surgery with 
the VERITASTM Vision System on the subjects.  The data from the system log files, the 
questionnaire, the operative report and other medical records will be used to assess the 
clinical utilization of the VERITASTM Vision System. 
JUSTIFICATION OF STUDY DESIGN:  
The study is being conducted to evaluate the overall clinical performance of the 
VERITASTM Vision System in human subjects and to confirm the overall surgeon 
acceptability.   

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5. 
ACRONYMS 
The following acronyms are used throughout the document:   
• 
ACD: Anterior Chamber Depth 
• 
AVG: Average Phaco Power 
• 
BCDVA: Best Corrected Distance Visual Acuity 
• 
D: Diopters 
• 
EPT: Effective Phaco Time 
• 
IEC: Independent Ethics Committee 
• 
IOP: Intraocular Pressure 
• 
IRB: Institutional Review Board 
• 
JJSV: Johnson & Johnson Surgical Vision 
• 
UCDVA: Uncorrected Distance Visual Acuity  
• 
UST: Ultrasonic Time  
6. 
STUDY OBJECTIVES AND ENDPOINTS 
The purpose of this study is to evaluate the overall clinical performance of the 
VERITASTM Vision System in human subjects and to confirm the overall surgeon 
acceptability.  
6.1 
ENDPOINTS 
Primary Endpoints: 
➢ Overall clinical performance will be evaluated based on surgeon’s ratings, 
system log files, operative report and other medical records for the following 
items: 
o Rating of anterior chamber stability 
o Rating of followability  
o Rating of holdability  
o Rating of Phaco (cutting) efficiency 
o Satisfaction with usability of VERITASTM Vision System 
o Overall satisfaction with VERITASTM Vision System  
Note: Surgeon rating will be on a scale from 1 to 5, defined as 1 – unsatisfied, 2- 
somewhat unsatisfied, 3 – neither satisfied nor unsatisfied, 4 – satisfied and 5 – 
very satisfied. Surgeon acceptability will be considered favorable for scores of 4 
and 5.  
 

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Other Endpoints: 
➢ Effective Phaco Time (EPT)  
➢ Ultrasonic Time (UST) 
➢ Average Phaco Power (AVG) 
➢ Volume of balanced salt solution (BSS) used 
➢ Satisfaction with VERITASTM Footpedal 
➢ Satisfaction with VERITASTM Swivel Handpiece 
➢ Rating of corneal clarity at 1-day post-op 
➢ Satisfaction with 1-day post-op clinical results of surgery with VERITASTM Vision 
System 
➢ Rate of adverse events and complications. 
Note: Other endpoints will be collected from surgeon’s ratings, system log files, 
operative report and other medical records. 
7. 
STUDY PRODUCTS 
The VERITASTM Vision System is intended to be used to perform cataract surgery by 
utilization of Phacoemulsification technique. VERITASTM aspirates the emulsified lens 
out of the chamber, and provides irrigation to help maintain the depth and pressure of 
the chamber. The VERITASTM Vision System’s sub-modes allow surgeons to also 
perform Diathermy (electrical cauterization) and Vitrectomy (a cutting action). 
A set of preprogrammed default surgical modes and settings are provided with the 
system.  The surgeon controls the various aspects of the surgical procedure by pre-
programming the system (via VERITASTM Footpedal, remote, and/or touch screen) for 
the surgeons’ specifications, and then using a VERITASTM Footpedal to control the 
modes and power output during surgery.  
The VERITASTM Vision System is designed to be used with OPO73, Advanced Infusion 
(AI) and Advanced Fluidics (AF) packs. These packs are dual pump fluidic tubing pack 
which interfaces with both the peristaltic and the vacuum-based pump related 
components.  Advanced Infusion (AI) pack supports both gravity-based irrigation and 
Gas Force Infusion (GFI), while Advanced Fluidics (AF) pack only supports gravity-
based irrigation.  
The VERITASTM Vision System is also designed to be compatible with VERITASTM 
Swivel Handpiece as well as the legacy Phaco Handpieces. However, VERITASTM 
Swivel Handpiece is designed to be used with VERITASTM Vision System only. The 
VERITASTM Swivel Handpiece is not intended for use with JJSV’s legacy Phaco 
systems.  

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The VERITASTM Vision System supports the newly developed VERITASTM Footpedal as 
well as the legacy JJSV’s Foot pedals.  
The VERITASTM Vision System is designed to be used with VERITASTM Remote Control 
only. It does not support legacy Remote Control. 
Note:  The clinical study will be performed with the VERITAS system and available, 
compatible accessories such as fluidics packs, handpiece, foot pedal and remote 
control. The components and accessories of the VERITAS system may be updated 
during the trial while ensuring that the system and accessories conform to the risk 
analysis and risk-benefit described in the protocol.  
8. 
STUDY POPULATION 
Each research subject must meet the following inclusion/exclusion criteria in order to 
participate in this study: 
Inclusion Criteria 
• 
Be at least 22 years old or older.  
• 
Cataracts for which cataract extraction and posterior chamber IOL implantation 
have been planned.  
• 
Availability, willingness, ability and sufficient cognitive awareness to comply with 
study protocol, examination procedures and visit. 
• 
Be willing to provide informed consent and authorization to disclose protected 
health information or equivalent documentation necessary to comply with 
applicable privacy laws pertaining to medical procedures in the governing 
countries. 
Exclusion Criteria 
• 
Expected surgical difficulties at the time of cataract extraction, which may 
increase the potential for complications (e.g., persistent bleeding, significant iris 
damage, uncontrolled intraocular pressure change, or significant vitreous 
prolapse or loss).  
• 
Subjects with only one good eye (e.g. amblyopic condition etc.).  
• 
Subjects with conditions associated with increased risk of zonular rupture, 
including capsular or zonular abnormalities that may lead to IOL decentration, 
including pseudoexfoliation, trauma, or posterior capsule defects.  
• 
History or current use of alpha-1 antagonist medication (e.g., Flomax).  
• 
Any condition which, in the Investigator's opinion, would make it unsafe (for the 
subject or for the study personnel) to treat the subject as part of this research 
study or for which cataract surgery is contraindicated.  
• 
Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils).  
• 
Is pregnant, or is breast feeding, or intend to become pregnant during the study. 

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• 
Concurrent participation or expected participation in an interventional (i.e., 
surgical or pharmaceutical interventional) clinical trial within 14 days prior to 
study screening. 
9. 
INVESTIGATOR SELECTION 
9.1 
INVESTIGATOR QUALIFICATIONS 
JJSV will select the existing cataract surgeons who are licensed to practice medicine 
and are experienced in performing the cataract surgeries at the investigative site. 
Investigators will be selected from the ophthalmologists who are experienced in 
performing phacoemulsification procedures(see Appendix E List of Potential 
Investigators and Sub-Investigators). Licensed ophthalmologists, optometrists and/or 
study coordinators with Good Clinical Practice (GCP) training and experience in 
conducting clinical trials in the fields of ophthalmology will consent subjects and perform 
screening as well as pre- and post-treatment testing. 
The sites where this trial will be conducted are required to have adequate staff support, 
as well as the necessary space and 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 only make changes to a protocol after notifying and obtaining approval from 
JJSV, the FDA or other governing agencies, and the IRB/IEC 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, with particular focus on assuring subjects are not improperly 
influenced or coerced toward participation. 
• 
Be responsible for the control and documentation of the devices under investigation. 
• 
Inform subjects that the device(s) are being used for investigational purposes and 
that requirements relating to obtaining informed consent and IRB/IEC 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 IRB/IEC approval. 
• 
Document in each subject’s case history that informed consent was obtained prior to 
participation in the study as required by 21CFR812. 

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• 
Report to JJSV and the reviewing IRB/IEC any adverse experiences that occur 
during 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) and/or the 
IRB/IEC. 
• 
Submit progress reports on the investigation to JJSV and the reviewing IRB/IEC at 
regular intervals, but no less often than yearly as required by 21CFR812.150. 
• Ensure the IRB/IEC 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 subjects to the IRB/IEC. 
• 
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/IEC, the 
FDA and the regulatory agency of the country in which the study is being conducted. 
• 
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/IEC.  All correspondence with the 
IRB/IEC should be retained in the Investigator Study Files/Notebook.  Copies of IRB/IEC 
submissions and approvals should be forwarded to JJSV.  Study sites will obtain 
IRB/IEC approvals and fulfill any other site-specific and/or region-specific regulatory 
requirements.  The investigator is required to report to JJSV within five working days any 
withdrawal of approval by the reviewing IRB/IEC for his/her participation in the 
investigation.  

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Prior to the start of subject enrollment, the following documents must be approved: 
• 
Confidentiality Agreement 
• 
Clinical Trial 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 (as available per country) 
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. 
9.4 
INVESTIGATOR INFORMATION 
Information on the principal investigator at each investigative site, the coordinating 
investigator, the address details for each investigative site and the emergency contact 
details for the principal investigator of each site are listed in a separate document - 
Study Investigator Information. 
10. 
EXPERIMENTAL PLAN 
10.1 OVERVIEW 
This study will be conducted in accordance with, the Declaration of Helsinki, ISO 
14155:2011 and all other applicable laws and regulations.  The study will not begin until 
regulatory and IRB/IEC approvals have been obtained. 
This study will be a prospective, open-label clinical investigation. Minimum 55 eyes and 
up to 150 eyes are expected to be treated.    
Key operative data include system settings, surgeons’ subjective rating on various 
aspects of the surgeries, system log files and reports, other medical records, medical 
complications, and adverse events during the study. 

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10.2 VISIT SCHEDULE 
There will be three study visits (Preoperative, operative and 1-2 days postoperative). 
The study visit schedule for all study subjects is outlined in Table 1. Unscheduled visits 
may be conducted as necessary at the discretion of the investigator for medically 
indicated follow-up.  
Table 1: Visit Schedule 
NAME OF 
VISIT 
VISIT 
VISIT WINDOW 
1 
Preoperative 
Within 45 days prior to surgery 
2 
Operative 
Day of surgery 
3 
1-Day Post-Op 
1-2 days postoperative 
 
10.3 PROCEDURES 
The procedures in the Pre-Op visit include Informed Consent as well as preoperative 
exams.  The procedures in the Operative Visit include cataract surgery with the 
VERITASTM Vision System and completion of the Questionnaire.  The procedures in the 
1-Day Post-Op visit include the UCDVA, slit lamp and other exams. 
Preoperative Procedures 
The Investigator or designee identifies potential study participants by reviewing medical 
records of subjects.  Potential study participants are scheduled for the study visits. 
Informed Consent 
At the visit, the Investigator or designee conducts the informed consent discussion and 
explains the study purpose, procedures, benefits, risks, discomforts, precautions and 
subject responsibilities to the potential study participant.  The Investigator may provide 
written delegation of authority to a trained and qualified study staff member (e.g., study 
coordinator, technician) to conduct the consent discussion; however, the Investigator 
should be available to answer the potential participant’s questions, as needed. 
Once the Investigator or designee has answered all the potential participant’s questions 
to his/her satisfaction and the potential study participant has voluntarily agreed to 
participate in the study, written informed consent is obtained using the IRB/IEC-
approved informed consent document.  The subject and the person conducting the 
consent discussion (Investigator or designee) print their names, sign and date the 
consent.  If the subject is unable to read, the consent document can be read to the 
subject in front of an impartial witness, who also prints his/her name, signs and dates the 
consent. 

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All subjects enrolled in the study must sign the current IRB/IEC-approved informed 
consent document.  The informed consent must be signed before any study-specific 
examinations are performed, and this must be documented in the source documents.  
An authorization for use/disclosure of health information form (HIPAA authorization) or 
similar medical measurement privacy law documentation must also be signed.   
The Investigator maintains the signed informed consent document and the signed 
authorization form as a permanent part of the subject’s medical records and provides a 
signed copy of the consent to the subject.  The Investigator or designee documents in 
the medical records that informed consent was obtained prior to any study-specific 
procedures and a copy of the signed consent was given to the subject. 
Potential participants who are approached with the informed consent document will be 
documented on the Subject Accountability Log.  A subject who does not meet the 
eligibility criteria or who chooses to discontinue study participation at any time is 
documented on the Subject Accountability Log as a Screen Failure or Exited Subject 
along with the reason. All subjects who sign the informed consent document are 
assigned a subject identifier. 
All preoperative testing for the study must be completed within 45 days prior to surgery.  
Data from routine (non-study-specific) preoperative cataract examinations performed 
prior to the informed consent process may be included, provided these tests are 
conducted no more than 45 days prior to surgery and the test date(s) are documented 
on the preoperative Case Report Form (CRF).  If a test/exam is required by the protocol 
but is not part of the routine testing the investigator performs for the cataract evaluation, 
that test/exam is considered to be study-specific and is not to be done until after the 
informed consent form has been signed by the subject.  Following the informed consent 
process, completion of the preoperative study exam and determination that the subject 
meets all of the required entrance criteria, the subject may be scheduled for surgery. 
Preoperative testing to be performed for each eye includes the following: 
Medical and Ocular History 
To determine the presence of any systemic or ophthalmic factors that may affect the 
subject’s eligibility based on the study inclusion and exclusion criteria in Section 8, the 
Investigator or designee obtain the subject’s medical and ophthalmic history at the visit, 
including assessment of:   
1) demographic information (age, gender, race/ethnicity);  
2) ophthalmic conditions and medications;  
3) history of ocular surgery, ocular injury, ocular infection, ocular inflammation, 
ocular allergy, eyelid abnormality, or ocular surface abnormality; 
4) pregnant and breastfeeding conditions, if applicable;  
5) recent participation in another ophthalmic clinical trial; 
6) employment or relationship with any employee at the clinical study site. 
Concomitant Medications (OCULAR/NON-OCULAR) 

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Any ocular or non-ocular medication the subject is taking should be recorded in the 
source documents. 
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 events.  See Section 11.0 
for further information. 
Ocular Symptoms (non-directed; spontaneous) 
Subjective ocular symptoms are to be assessed at the preoperative 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, night glare or starbursts, the 
level of severity should be determined (mild, moderate or severe). 
Biomicroscopic Slit-Lamp Exam   
A biomicroscopic slit-lamp exam must be performed at the study visit to determine if the 
subject meets inclusion/exclusion criteria.  The Investigator or designee evaluates the 
eyelids, palpebral and bulbar conjunctiva, cornea, anterior chamber, iris, lens and other 
parts of eye using a slit lamp biomicroscope.  The Investigator or designee assesses the 
findings for the presence of any medical findings. 
Distance Visual Acuity Testing  
Monocular uncorrected distance visual acuity (UCDVA) is to be measured for each eye 
using an ETDRS chart or per the site’s standard of care. 
Intraocular Pressure (IOP)  
Intraocular pressure (IOP) is to be measured for each eye using the investigator’s usual 
methods (e.g., Goldmann applanation or tonopen).  It is recommended that the same 
methods be used for all study subjects at the site for the duration of the study. 
Anterior Chamber Depth (ACD) 
Anterior Chamber Depth is to be measured for each eye using the investigator’s usual 
methods.  
Corneal Densitometry 
The corneal densitometry is to be measured through Pentacam, Galilei G6 or other 
corneal densitometry system at the designated visits. The same corneal densitometry 
device is to be used throughout the duration of the study. 
Additional Preoperative information to be collected: 

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• 
Cataract type and density for each eye 
• 
Planned surgery date 
Operative Procedures 
The investigator should use his or her standard, small-incision, cataract extraction 
surgical technique.  Each surgeon will be trained on the use of the VERITASTM Vision 
System. The surgeries are to be video recorded through surgical microscope and digital 
video recorder. 
Clinical Assessment 
The following variables will be recorded as quantitative data to assess system clinical 
performance during the phacoemulsification procedure.  These data will be used to 
understand optimal system settings.  
• 
Effective Phaco Time (EPT) 
• 
Ultrasonic Time (UST) 
• 
Average Phaco Power (AVG) 
• 
Volume of balanced salt solution (BSS) used: A member of surgery team shall 
note the volume of BSS left in the BSS bottle/bag before and after each surgery, 
to assess the volume used for each case.  
Questionnaire   
The surgeon will complete a questionnaire (the first 15 questions within the 
questionnaire) related to the use of the investigational study device for each subject 
following surgery (Appendix D). 
Biomicroscopic Slit-Lamp Exam   
A biomicroscopic slit-lamp exam is be performed after surgery completion at the same 
day of operative visit to assess corneal clarity and determine the presence or absence of 
any medical or lens findings, complications or adverse events.  
Additional operative information collected includes: 
• 
Date of surgery 
• 
Operative eye 
• 
Product deficiencies / complaints 
• 
Operative report and system log files. 
• 
Device deficiencies/Complications/Adverse events 
• 
Ocular medications 
 

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Postoperative Procedures 
Postoperatively, subjects will be examined according to the schedule in Section 10.2, 
Visit Schedule.  After each surgery, the treated eye will be examined 1 day 
postoperatively (1-2 days).  The postoperative case report form will include the following 
information (Appendix A): 
Distance Visual Acuity Testing  
Monocular UCDVA and best corrected distance visual acuity (BCDVA) will be measured 
for all subjects postoperatively using an ETDRS chart or per site’s standard of care. 
Biomicroscopic Slit-Lamp Exam   
A biomicroscopic slit-lamp exam must be performed at the postoperative visit to 
determine the presence or absence of any medical or lens findings, complications or 
adverse events.  
Findings of aqueous cells and flare, corneal edema, corneal clarity, posterior capsule 
striae (wrinkles), and posterior capsule opacification 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 C.   
Intraocular Pressure (IOP)  
Intraocular pressure (IOP) is to be measured using the investigator’s usual methods 
(e.g., Goldmann applanation or tonopen). 
Anterior Chamber Depth (ACD) 
Anterior Chamber Depth is to be measured using the investigator’s usual methods.  
Corneal Densitometry 
The corneal densitometry is to be measured through Pentacam or Galilei G6 at the 
designated visit. The same corneal densitometry device is to be used throughout the 
duration of the study. 
Ocular Symptoms (non-directed; spontaneous) 
Subjective ocular symptoms are to be assessed at the 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, night glare or starbursts, the 
level of severity should be determined (mild, moderate or severe). 
Questionnaire   
The surgeon will complete the last 2 questions within the questionnaire related to the 
use of the investigational study device for each subject at 1-Day postoperative visit 
(Appendix D). 
 

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Concomitant Medications   
Postoperative medications should be used as is customary for each investigator and 
recorded in the source document for each subject.  Medications will be recorded on each 
postoperative case report form as applicable. 
Complications 
Any postoperative complications must be reported via a case report form. 
Adverse Events / Device deficiencies / Complications 
Subjects should be assessed at the visit for occurrence of and/or change in status of any 
adverse events, particularly serious and/or device-related events, as well as any device 
deficiencies / complications.  See Section 11.0 for further information. 
10.4 VERITASTM VISION SYSTEM SUPPLY 
For all the study subjects, the VERITASTM Vision System will be supplied by JJSV prior 
to the first study treatment. At the completion of all study treatments, the VERITASTM 
Vision System will be shipped back to JJSV following the final accountability by a JJSV 
Study Monitor.  At all times, the storage, access and use of the VERITASTM Vision 
System must be controlled.   
10.5 EXIT OF SUBJECTS 
An Exit Case Report Form will be completed for all subjects, either when they complete 
the study or if they exit early.    
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.  
A subject will be considered a “screen failure” if he/she does not meet the 
inclusion/exclusion criteria or if consent is withdrawn prior to cataract surgery.   
If a subject is exited early from the study, the investigator or designee will complete an 
Exit Case Report Form indicating the reason for study exit.  In the event of any serious 
adverse event, the subject may be exited from the study; however, efforts must be made 
by the investigator to follow the subject until resolution of the adverse event.   
Following study completion or early exit, all study subjects are to be instructed to 
undergo regular eye examinations at least yearly and to return to their doctor if any eye 
complications are experienced in the interim. 
10.6 UNSCHEDULED VISITS 
During the study period or immediately after (within 1-week), 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 

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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 case report form. 
10.7 PROTOCOL DEVIATIONS 
Any departure from the protocol procedures represents a protocol deviation.  Protocol 
deviations may be subject-based (e.g., inclusion/exclusion criteria, informed consent 
deviation, etc.) or procedural-based (e.g., out-of-interval visits, non-compliance with 
testing procedures, etc.).  All protocol deviations will be documented in CTMS system.  
Any deviation made to protect the life or physical wellbeing 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 
JJSV, and if the non-compliance is persistent or egregious, JJSV 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/IEC of instances of 
protocol non-compliance in accordance with the IRB/IEC requirements. 
11. 
ADVERSE EVENTS AND PRODUCT COMPLAINTS 
11.1 DEFINITIONS 
Adverse Event (AE) 
An adverse event is defined (following 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 (following 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 
Device-Related Adverse Event/Adverse Device Effect (ADE) 
A device-related adverse event is defined as any adverse even that is believed to be 
definitely, probably or possibly related to the study device.  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 

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instructions for use, deployment, implantation, installation, operation of any malfunction 
of the device.   
Study-Specific Anticipated Adverse Events 
The study specific anticipated AEs are listed below and will be classified as AE or SAE 
dependent upon its occurrence and severity during the course of the study: 
• 
Worsening of vision compared to baseline 
• 
Sub-conjunctival Hemorrhage 
• 
Loss of corneal clarity 
• 
Inflammation that requires additional intervention (e.g. additional or increase in 
topical steroids outside of the normal post-operative regimen) 
• 
Infections 
• 
Retinal detachment 
• 
Pupil changes 
• 
Glaucoma 
• 
Corneal burn 
• 
Eye contamination (such as endophthalmitis) 
• 
Subject or user injury (such as pinch, cut, bruise) 
• 
Posterior capsular tear (can lead to vitreous traction, vitreous loss, and/or 
posterior dislocation of the cataractous lens) 
• 
Anterior capsular tear (can lead to Intraocular lens (IOL) unable to be placed in 
capsular bag) 
• 
Significant endothelial cell loss 
• 
Electrical shock 
• 
Burn (second degree) 
• 
Laceration 
• 
Irregular pupil or iris damage 
• 
Vitreous Wick Syndrome 
 
Study-Specific Serious Anticipated Adverse Events 
The following is a list including, but not limited to, ocular adverse events 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/or other appropriate 
regulatory agencies.  
• 
Endophthalmitis/Intraocular infection  
• 
Hypopyon  
• 
Hyphema  
• 
Cystoid macular edema  
• 
Pupillary block  
• 
Retinal detachment/tear  
 

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• 
Persistent iritis  
• 
Raised IOP requiring treatment  
• 
Toxic anterior segment syndrome (TASS) 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) 
Any UADE (USA 21CFR 812.3(s)) or USADE (ISO 14155) is defined as any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan (i.e., this protocol), 
application (including a supplementary plan or application), or risk assessment, or any 
other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects.   
11.2 PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION 
A product complaint/device deficiency is defined (21 CFR 820.3(b) and ISO 14155) as 
any alleged deficiency related to the identity, quality, durability, reliability, safety, 
effectiveness, or performance of a device. This may include malfunctions, use error and 
inadequacies in labeling.  Product complaints can pertain to any marketed JJSV device 
being used in the study.  The investigator is to assess whether the deficiency could have 
led to a serious adverse event without suitable action or intervention or under less 
fortunate circumstances. 
11.3 ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS 
All adverse events and any complaint encountered using any JJSV product, regardless 
of severity and whether 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 (see Appendix E).  Adverse events are also to be 
reported to the reviewing IRB/IEC as per the IRB/IEC’s reporting requirements.  If 
required, adverse events will be reported to the appropriate regulatory agencies 
according to all applicable laws and regulations.   
Reporting of adverse events shall follow ISO 14155 and country-specific guidelines, of 
which the shortest/strictest timeline requirement for reporting adverse events will be 
followed.  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/IEC 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 either recording 
complaints on the CRF when the complaint occurred (e.g. operative form) or by a phone 
call to the Sponsor.  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/IEC per their reporting requirements. 
Serious and/or Device-Related Adverse Event Reporting 
Serious and/or device related events (ADEs) are to be documented using the Serious 
Adverse Event/Adverse Device Effect (SAE/ADE) CRF.  In the event of a serious 
adverse event (SAE), which may or may not be related to use of the study device, JJSV 
must be notified immediately (no later than 24 hours after detection).  Any SAE is to be 
reported by phone (and/or email) and by submitting the completed SAE/ADE CRF.  Any 
SAE or device-related AE should also be reported to the investigator’s IRB/IEC 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 24 hours, and to 
the investigator’s IRB/IEC 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 
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 

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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.  Obtain and maintain in the subject's files all 
pertinent medical data relating to the event including the subject’s medical records and 
medical reports and/or judgments from colleagues or outside specialists who assisted in 
the measurements 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.  A SAE/ADE 
Follow-up CRF should be completed each time the subject returns to the investigator for 
follow-up of serious and/or device-related adverse event until resolution of the event.  
Any subject who is exited from the study due to a serious and/or device-related adverse 
event or prior to resolution of such an event will be followed until the outcome is 
determined. 
12. 
PROTOCOL CHANGES/AMENDMENTS 
If the investigator desires 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 
of the governing IRB/IEC prior to implementation.   
13. 
ETHICS REVIEW AND SUBJECT WELFARE 
13.1 INDEPENDENT ETHICS COMMITTEE (IEC) OR 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/IEC.  All correspondence with the 
IRB/IEC should be retained in the Investigator Notebook.  Copies of IRB/IEC 
submissions and approvals should be forwarded to JJSV. 

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The investigator is responsible for notifying the IRB/IEC 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/IEC-approved study informed consent must be signed by 
each study subject prior to any study-specific examinations being performed.  The 
IRB/IEC-approved informed consent 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 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 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 21CFR812 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 measurement in the governing countries.   
NOTE:  The sponsor will secure appropriate insurance for study subjects prior to study 
start. 
14. 
DOCUMENTATION 
14.1 SOURCE DOCUMENTS 
Source documents must be kept for all study subjects.  Source documents may include 
a subject’s medical records, hospital charts, clinic charts, the investigator’s subject study 
files, as well as results of any diagnostic tests or procedures such as topographies or 
laboratory tests with photographs or instrument printouts. 
Each site is expected to adhere to the clinic’s own standard documentation requirements 
for medical charts/clinic notes.  However, 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 JJSV: 
• 
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)  
• 
Dates of all subject visits throughout the duration of the study 
• 
Concurrent medications 
• 
Study measurements 

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• 
Description of any adverse events and/or product complaints/device deficiencies 
and documentation of appropriate reporting 
• 
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 the 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 a paper or electronic data capture 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 JJSV.  
14.4 STUDY SUMMARY 
A final investigator’s summary will be provided to JJSV and the reviewing IRB/IEC within 
3 months after termination or the completion of the study or the investigator’s part of the 
investigation.  
15. 
MONITORING  
JJSV 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, JJSV 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.  
To minimize data omissions and inconsistencies on clinical reports and to ensure that 
data are accurately transcribed to computer data files, JJSV 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 on the case report forms at the investigative site and in the data management 
system at JJSV. 
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 
centralized and on-site programs.  In addition, subjects will be encouraged at the time of 

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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, as needed for 
compliance with study requirements. 
Device Accountability 
Complete Activator accountability will be maintained at the investigative site by 
maintaining records of investigational product received from and returned to JJSV.  A 
site log will be used to track investigational equipment for date of receipt, use and 
disposition/return to JJSV.  This site log and any other investigational product 
information will be maintained in the study binder and monitored by JJSV personnel.  
During periodic investigative site monitoring visits, JJSV personnel will review 
investigative product inventory records and logs to ensure Activator accountability 
compliance and complete investigational traceability.   
Site Monitoring Plan 
Prior to performing site initiation, 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 JJSV or have undergone significant 
changes, or have not been visited in the past year.  A study initiation visit will be 
conducted (either in-person or via a web-based meeting) for all sites prior to or at the 
time of the first study procedure.  A study initiation visit may be conducted prior to the 
first treatment.  
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, JJSV 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.  
JJSV 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.   
Training on study-specific procedures may also be conducted during monitoring visits.  
Upon study completion, a final close-out site visit to each site will be made 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 JJSV, 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 
For the VERITASTM Vision System, residual risks with rating of medium to the subjects 
and operators can be grouped into possible induced harms; 
1) Corneal burn 
2) Eye contamination – such as endophthalmitis 
3) Subject or user injury– such as pinch, cut, bruise 
4) Posterior capsular tear – can lead to vitreous traction, vitreous loss, and/or 
posterior dislocation of the cataractous lens 
5) Anterior capsular tear – can lead to IOL unable to be placed in capsular bag 
6) Endothelial cell loss 
7) Electrical shock 
8) Burn (second degree) 
9) Environment: Fire 
10) Laceration 
11) Irregular pupil or Iris Damage 
12) Vitreous Wick Syndrome 
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 JJSV 
according to Section 11.0, Adverse Events and Product Complaints.  Additionally, JJSV 
will monitor incoming data following the procedures outlined in Section 15.0, Monitoring.  
The Medical Monitor will ensure subjects are not exposed to additional risks by 
monitoring serious adverse events, device-related adverse events, and device-
deficiencies that could have led to serious adverse events (Section 15.3, Safety 
Monitoring).  
Potential Benefits 
The subjects may experience the following benefits: 
• 
Rapid visual rehabilitation and alleviation of symptoms due to cataract. 
• 
Early resumption of daily activities 
• 
Minimal ocular inflammation 
• 
Minimal postoperative astigmatism 
• 
Reduced potential for ocular complications 
 
Subjects who are participating in this trial may benefit from improved visual outcomes 
due to the phacoemulsification procedure.   
Conclusion 
The hazards/risks associated with the VERITASTM Vision System are acceptable and 
within those of JJSV’s other phacoemulsification systems. The potential clinical benefits 
of the VERITASTM Vision system 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 use of all study products, and original case report forms 
should be maintained by the investigator.   
The investigator must maintain and have access to the following essential documents 
until notified by the Sponsor.  Note: This may be for a minimum of 15 years after 
completion of the study unless country-specific requirements are longer. JJSV 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 (detailed adverse event forms, follow-up letters, 
etc.) 
• 
Investigational supply records/inventory 

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• 
IRB/IEC approval documentation 
• 
Study correspondence  
• 
Study agreements 
• 
Site visit documentation 
• 
Protocol(s) and the reason for any deviations from the protocol 
• 
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 or equivalent 
documentation necessary to comply with applicable privacy laws pertaining to 
medical treatment in the governing countries) 
• 
Subject medical chart/clinic notes (Not applicable for transfer of ownership to 
JJSV) 
 
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 IRB/IEC, 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/IEC and regulations of the FDA and governing countries.  The 
study will be terminated if causality is shown to be related to the study device. 
Additionally, the investigator, or JJSV, may stop a subject’s participation at any time.  
JJSV 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 
20.1 ANALYSIS POPULATION 
All subjects treated who have available data will be considered the safety population and 
used for all analyses. 
20.2 STUDY ENDPOINTS 
Primary Endpoints: 
➢ Overall clinical performance will be evaluated based on surgeon’s ratings and 
system log files, operative report and other medical records for the following 
items: 

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o Rating of anterior chamber stability 
o Rating of followability  
o Rating of holdability  
o Rating of Phaco (cutting) efficiency 
o Satisfaction with usability of VERITASTM Vision System 
o Overall satisfaction with VERITASTM Vision System  
Each of the questions will have a surgeon’s rating score. The frequency and proportion 
of surgeon’s ratings for each of the questions on a 1-5 rating scale will be reported. 
Clinical performance will be considered favorable for rating scores of 4 and above. The 
proportion and the associated 95% confidence interval of the rating scores of 4 and 
above for each question will be computed.  
 
OTHER ENDPOINTS 
➢ Effective Phaco Time (EPT)  
➢ Ultrasonic Time (UST) 
➢ Average Phaco Power (AVG) 
➢ Volume of balanced salt solution (BSS) used 
➢ Satisfaction with VERITASTM Footpedal 
➢ Satisfaction with VERITASTM Swivel Handpiece 
➢ Rating of corneal clarity at 1-day post-op 
➢ Satisfaction with 1-day post-op clinical results of surgery with VERITASTM Vision 
System 
➢ Rate of adverse events and complications. 
Summary statistics will be reported for the above endpoints. Continuous variables will be 
summarized by mean, standard deviation, minimum and maximum. Categorical 
variables will be reported by frequency and proportion.     
20.3 SAMPLE SIZE CALCULATIONS 
Minimum 55 eyes and up to 150 eyes will be treated to gain further surgeon experience 
with the new system. 
A two-sided 95% confidence interval for an expected proportion of 0.95 using the large 
sample normal approximation will extend 0.058 (i.e., the precision of 5.8%) with a 

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sample size of 55 eyes and will extend 0.035 (i.e., the precision of 3.5%) with a sample 
size of 150 eyes. 

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APPENDIX A. SUMMARY OF PROCEDURES REQUIRED  
                  
     a Includes determination of ocular and lens findings/complications.  
     b The first 15 questions within the questionnaire, ratings at Operative Visit. 
     c The last 2 questions within the questionnaire, ratings at 1-Day Post-Op Visit. 
 
Procedures 
Visit 1: 
Preoperative 
Visit 
Visit 2: 
Operative 
Visit 
Visit 3: 
1-Day Postoperative 
Visit 
Informed consent 
X 
 
 
Medical and Ocular History, 
inclusion/exclusion criteria 
X 
 
 
BCDVA (Monocular) 
 
 
X 
UCDVA 
X 
 
X 
Intraocular Pressure (IOP) 
X 
 
X 
Slit-lamp Exam a 
X 
X 
X 
Anterior Chamber Depth (ACD) 
X 
 
X 
Corneal Densitometry 
X 
 
X 
Phacoemulsification Surgery 
 
X 
 
Concomitant Medications (Ocular/Non 
Ocular) 
X 
X 
X 
Complications 
 
X 
X 
Adverse events (Ocular/Non Ocular) 
X 
X 
X 
Device deficiencies/complaints 
 
X 
X 
Ocular/visual Symptoms (Non-directed) 
X 
 
X 
Surgeon Questionnaire 
 
Xb 
Xc 

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APPENDIX B.  EQUIPMENT LIST 
The following equipment will be supplied to an investigative site for the duration of the 
study provided that the site does not already have such equipment available for use.  
This equipment loan will be documented in the Equipment Use Agreement or Clinical 
Trial Agreement, which indicates that the equipment is to be returned to JJSV at the 
completion of the study. 
• 
VERITASTM Vision System, which may include: 
o VERITASTM Console with Power Cord 
o VERITASTM Footpedal with Cable 
o VERITASTM Swivel Handpieces system 
o VERITASTM Remote Control 
o Phaco Pack (one for each case) 
▪ 
Advanced Fluidics Pack 
▪ 
Advanced Infusion Pack 
• 
Solo I/A handpieces (if needed) 
• 
Cart (if needed) 
o Mounting Plate 
o Motorized IV Pole 
• 
Diathermy forceps or pencil handpieces, plus cables (if needed) 
• 
6 - 20 gauge vitrectomy kits, including 20 gauge irrigation sleeves (if needed) 
• 
Phaco Tips (if needed)   
o 
20 gauge phaco tips - 0⁰, 30⁰ straight, curved 30⁰, plus sleeves 
o 
21 gauge phaco tips - 0⁰, 30⁰ straight, curved 30⁰, plus sleeves  
• 
Digital video recorder and accessories to attach it to microscope (if needed) 
 
Additional ancillary supplies may be provided to the site depending on their needs 
and surgical setup.  
 
 
 

 
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APPENDIX C. SLIT-LAMP EXAM RATINGS 
The Investigator or designee assesses the findings for the presence of any medical 
findings. 
A)  Ratings of Aqueous Cells and Flare 
For consistency, the SUN (Standardization of Uveitis Nomenclature) Working Group 
Grading Scheme is to be used for grading of anterior chamber cells and flare as reported 
in: Standardization of uveitis nomenclature for reporting clinical data.  Results of the first 
international workshop; The standardization of uveitis nomenclature (SUN) working 
group.  Am J Ophthalmol 2005;140:509-516. 
CELLS 
Grade 
Cells in Field (Field is a 1x1 mm slit beam) 
0 
<1 
0.5+ 
1 - 5 
1+ 
6 - 15 
2+ 
16 - 25 
3+ 
26 - 50 
4+ 
>50 
 
FLARE 
Grade 
Description 
0 
None 
1+ 
Faint 
2+ 
Moderate (iris and lens details clear) 
3+ 
Marked (iris and lens details hazy) 
4+ 
Intense (fibrin or plastic aqueous) 
B)  Ratings of Corneal Edema 
Corneal edema should be classified according to the haziness of the epithelium, the 
number of microcysts observed, and the clouding of the stroma. 
Amount 
Grade 
Description 
None 
0 
Normal transparency: 
a. No epithelial or sub-epithelial haziness 
b. No microcysts 
c. No stromal cloudiness 

 
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Amount 
Grade 
Description 
Trace 
+1 
a. Barely discernable localized epithelial or sub-epithelial 
haziness, and/or 
b. 1 to 20 microcysts, and/or 
c. Barely discernable localized stromal cloudiness 
Mild 
+2 
a. Faint but definite localized or generalized epithelial, 
sub-epithelial or stromal haziness/cloudiness, and/or 
b. 21-50 microcysts 
Moderate 
+3 
a. Significant localized or generalized epithelial, sub-
epithelial or stromal haziness/cloudiness and/or 
b. 51-100 microcysts 
Severe 
+4 
a. Definite widespread epithelial or stromal cloudiness, 
giving dull glass appearance to cornea or numerous 
coalescent bullae (please note the number and 
location of bullae), and/or 
b. >100 microcysts or bullae, and/or 
c. Numerous striae (please note the number and location 
of striae or folds) 
C)  Ratings of Corneal Clarity 
Corneal clarity should be classified according to the haziness and its effect on refraction. 
Corneal Clarity 
0 
Clear Cornea 
1 
Mild haze 
2 
Moderate haze 
3 
Dense haze / prevents refraction, Anterior Chamber visible 
4 
Dense haze / Anterior Chamber not visible 
D) Posterior Capsule Striae Grading Scale 
The following five-point grading scale is to be used for rating striae in the posterior 
capsule: 
Amount 
Grade 
Description 
None 
0 
None 
Trace 
+1 
One detectable, barely noticeable striae 
Mild 
+2 
One or two prominent striae 
Moderate 
+3 
Three or more prominent striae, but visibility of retina 
is not impacted 
Severe 
+4 
Three or more prominent striae affecting visualization 
of retina 

 
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E).  Posterior Capsule Opacification Grading Scale 
Below is the five-point grading scale to be used for PCO determination: 
Amount 
Grade 
Description 
None 
0 
Normal posterior capsule with no area of opacity.  Red reflex 
bright. 
Trace 
+1 
Some loss of transparency involving the posterior capsule.  Red 
reflex fairly bright 
Mild 
+2 
Mild loss of transparency with cloudiness extending through 
most of the posterior capsule.  There may be a few Elschnig’s 
pearls in the posterior capsule.  Red reflex mildly diminished. 
Moderate 
+3 
Moderate loss of transparency with difficulty visualizing the 
retina.  There may be multiple Elschnig’s pearls in the posterior 
capsule.  Red reflex markedly diminished. 
Severe 
+4 
Posterior capsule very opaque with inability to view the retina.  
The posterior capsule may have confluent Elschnig’s pearls and 
fibrous scarring.  Red reflex barely visible. 
 

 
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APPENDIX D. NEXT GENERATION PHACO SYSTEM (VERITASTM VISION SYSTEM) 
PERFORMANCE RATING QUESTIONNAIRES 
VERITASTM Vision System Performance Rating at Operative Visit 
The following questions should be completed by the surgeon after completion of 
each of the study cases. 
Unsatisfied 
Somewhat 
Unsatisfied 
Neither Satisfied  
nor Unsatisfied 
Satisfied 
Very 
satisfied 
Not 
Applicable 
1 
2 
3 
4 
5 
N/A 
Rate the following regarding your satisfaction with the VERITASTM Vision System, 
using 1 - 5 scale above. Your acceptability will be considered favorable for scores 
of 4 and 5.  
If you rate a score of 1 or 2 on a question, please provide the feedback on the 
corresponding comment space. 
 
Subject Study ID: ______________          Study Eye: OD / OS 
 
Surgeon: ________________ 
Date: ________________  
 
1. Rating of satisfaction with responsive fluidics to quickly achieve and maintain 
chamber stability:                                         
1     2     3     4     5    N/A 
 
Comments:    
 
 
 
 
 
 
 
 
 
 
 
2. Rating of satisfaction with post-occlusion surge: 
1     2     3     4     5    N/A 
 
Comments:    
 
 
 
 
 
 
 
 
 
 
 
3. Rating of overall satisfaction with achieving and maintaining excellent anterior 
chamber stability: 
1     2     3     4     5    N/A 
Comments:    
 
 
 
 
 
 
 
 
 
 
4. Rating of satisfaction with followability: 
1     2     3     4     5    N/A 
Comments:    
 
 
 
 
 
 
 
 
 
 

 
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5. Rating of satisfaction with holdability:  
1     2     3     4     5    N/A 
Comments:    
 
 
 
 
 
 
 
 
 
 
 
6. Rating of satisfaction with Phaco (cutting) efficiency:  1     2     3     4     5    N/A 
 
Comments:    
 
 
 
 
 
 
 
 
 
 
 
7. Rating of satisfaction with corneal clarity at same day post-op:  
 
 
1     2     3     4     5    N/A 
Comments:    
 
 
 
 
 
 
 
 
 
 
 
8. Rating of satisfaction with enhanced ergonomics of VERITASTM Footpedal:       
 
1     2     3     4     5    N/A 
Comments:    
 
 
 
 
 
 
 
 
 
 
 
9. Rating of overall satisfaction with VERITASTM Footpedal:        
 
1     2     3     4     5    N/A 
Comments:    
 
 
 
 
 
 
 
 
 
 
 
10. Rating of satisfaction with weight and size of VERITASTM Swivel Handpiece:          
1     2     3     4     5    N/A 
Comments:    
 
 
 
 
 
 
 
 
 
 
 
11. Rating of satisfaction with surgeon control of VERITASTM Swivel Handpiece:          
1     2     3     4     5    N/A 
Comments:    
 
 
 
 
 
 
 
 
 
 
12. Rating of overall satisfaction with VERITASTM Swivel Handpiece:          
1     2     3     4     5    N/A 
Comments:    
 
 
 
 
 
 
 
 
 
 

 
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13. Rating of satisfaction with usability of VERITASTM Vision System:  
 
1     2     3     4     5    N/A 
Comments:    
 
 
 
 
 
 
 
 
 
 
 
14. Overall rating of satisfaction with VERITASTM Vision System:  
 
1     2     3     4     5    N/A       
Comments:   
 
 
15. Please comment on any pertinent observations you have after using the 
VERITASTM Vision System: 
Comments:   
 
 
 
 
 
 
 
Surgeon Signature and Date:  ___________________________________ 
 
 
 
 

 
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VERITASTM Vision System Performance Rating  
at 1-Day Postoperative Visit 
The following questions should be completed by the surgeon after completion of 
each of the study cases. 
Unsatisfied 
Somewhat 
Unsatisfied 
Neither Satisfied  
nor Unsatisfied 
Satisfied 
Very 
satisfied 
Not 
Applicable 
1 
2 
3 
4 
5 
N/A 
Rate the following regarding your satisfaction with the VERITASTM Vision System, 
using 1 - 5 scale above. Your acceptability will be considered favorable for scores 
of 4 and 5.  
If you rate a score of 1 or 2 on a question, please provide the feedback on the 
corresponding comment space and share why it’s rated as such. 
 
Subject Study ID: ______________          Study Eye: OD / OS 
 
Surgeon: ________________ 
Date: ________________  
 
1. Rating of satisfaction with corneal clarity at 1-Day Post-Op:  
 
 
1     2     3     4     5    N/A 
Comments:    
 
 
 
 
 
 
 
 
 
 
 
2. Rating of satisfaction with 1-Day Post-Op clinical results of surgery with 
VERITASTM Vision System (based on the results of UCDVA, corneal clarity, 
adverse event rate, and other relevant clinical assessment):  
1     2     3     4     5    N/A 
Comments:    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Surgeon Signature and Date:  ___________________________________ 
 
 

 
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APPENDIX E. ADVERSE EVENT AND COMPLAINT REPORTING INSTRUCTIONS 
All adverse events and complaints related to using JJSV products must be reported to 
JJSV.   
All adverse events and complaints: 
For events that are not considered serious or related to the study device: 
1. Record the event and/or complaint on the case report form that corresponds to 
the visit during which awareness of the event occurred.  Additionally, a complaint 
may be reported via a telephone call to JJSV. 
2. Complete the case report form (CRF) in a timely manner. 
Serious Adverse Events or device deficiencies that may have led to a serious 
event 
In the event of a serious event (i.e., life- or sight-threatening incident) whether or not 
related to the device, or a device deficiency that may have led to a serious event, the 
investigator shall: 
1. Notify JJSV immediately (no more than 24 hours after learning of the 
event) as follows:  
a. Contact the following JJSV personnel by phone and/or email: 
               
      
               Office: 
 
 
Cell: 
 
 
b. Complete an Adverse Event Form and submit to JJSV  
 
Non-serious, device-related Events: 
For events that are not considered serious but are believed related to the study device 
(ADEs): 
1. Complete an Adverse Event Form 
2. Ensure the data are submitted to JJSV within a timely manner.  
 
 
 
 

 
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APPENDIX F. LIST OF POTENTIAL PRINCIPAL INVESTIGATORS AND SUB-
INVESTIGATORS  
 
List of Potential Principal Investigators (PIs) and Sub-Investigators (Sub-Is) 
No. 
Name 
Location 
1 
 
San Salvador, El Salvador 
2 
 
San Salvador, El Salvador 
3 
  
IN, USA 
4 
  
WI, USA 
5 
 
CA, USA 
6 
 
OH, USA 
7 
 
NY, USA 
8 
 
SD, USA 
9 
 
CA, USA 
10 
 
FL, USA 
11 
 
CA, USA 
12 
 
CA, USA