Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)
Phase: NA
Conditions: Cataract, Corneal Astigmatism
Sponsor: Johnson & Johnson Surgical Vision, Inc.

 
 
Study Protocol 
 
 
POST-MARKET EVALUATION OF SURGEON 
FEEDBACK ON 
TECNIS® TORIC II INTRAOCULAR LENS (IOL) 
 
 
NCT Number: NCT04210232 
Document date: 20 January 2020 
 
 
 
 
 
 

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PR/NXGT-201-TTL2 
CONFIDENTIAL 
The following contains confidential, proprietary information  
that is the property of Johnson & Johnson Surgical Vision, Inc. 
 
Post-market Evaluation of Surgeon Feedback on  
TECNIS® TORIC II Intraocular Lens (IOL) 
PROTOCOL NUMBER:  NXGT-201-TTL2 
 
SPONSOR:  Johnson & Johnson Surgical Vision, Inc.  (JJSV) 
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; applicable ISO 14155 and all 
other regulations; conditions of approval imposed by the reviewing Institutional 
Review Board (IRB); Ethics Committee (EC) and other regulatory agencies; 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., authorization 
or equivalent). 
• Maintain all information supplied by Johnson and Johnson Surgical Vision in 
confidence and, when this information is submitted to an independent IRB, EC or 
any other group, it will be submitted with a designation that the material is 
confidential. 
 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
 
 
 
 
 
Investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
 
 
Sub-investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
 
 
Sub-investigator Printed Name 
Signature 
Date 

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TABLE OF CONTENTS 
 
TITLE 
PAGE 
 
Personnel and Facilities............................................................................................. 4 
Protocol Change History............................................................................................ 5 
1. 
Synopsis ......................................................................................................... 7 
2. 
Background/Introduction.............................................................................. 10 
3. 
Clinical Hypothesis ....................................................................................... 10 
4. 
Study Design................................................................................................. 10 
5. 
Acronyms ...................................................................................................... 10 
6. 
Study Endpoints ........................................................................................... 11 
6.1 
Primary Endpoint .......................................................................................... 11 
6.2 
Other endpoints ............................................................................................ 12 
7. 
Study Products ............................................................................................. 12 
7.1 
Intraocular lens ............................................................................................. 12 
7.2 
Implantation Systems.................................................................................... 14 
8. 
Study Population .......................................................................................... 15 
8.1 
Inclusion Criteria ........................................................................................... 15 
8.2 
Exclusion Criteria.......................................................................................... 15 
9. 
Investigator Selection ................................................................................... 16 
9.1 
Investigator Qualifications ............................................................................. 16 
9.2 
Investigator Obligations ................................................................................ 16 
9.3 
Investigator Approval .................................................................................... 17 
9.4 
Investigator information................................................................................. 18 
10. 
Experimental Plan ......................................................................................... 18 
10.1 Overview ...................................................................................................... 18 
10.2 Visit Schedule............................................................................................... 19 
10.3 Preoperative Procedures .............................................................................. 19 
10.4 Study lens supply ......................................................................................... 21 
10.5 Selection of the IOL ...................................................................................... 21 
10.6 OPERATIVE PROCEDURES ....................................................................... 21 
10.7 Postoperative Procedures ............................................................................. 23 
10.8 Exit of Subjects............................................................................................. 24 
10.9 Unscheduled Visits ....................................................................................... 25 
10.10 Protocol Deviations ....................................................................................... 25 
11. 
Adverse Events and Product Complaints .................................................... 26 
11.1 Adverse Event Definitions ............................................................................. 26 

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11.2 Product Complaint/Device Deficiency Definition............................................. 27 
11.3 Adverse Event and Complaint Reporting Requirements................................. 28 
11.4 Causal Relationship ...................................................................................... 28 
11.5 Adverse Event Follow-up .............................................................................. 29 
12. 
Protocol Changes/Amendments .................................................................. 29 
13. 
Ethics Review and Patient Welfare............................................................... 30 
13.1 Institutional Review Board (IRB).................................................................... 30 
13.2 Informed Consent ......................................................................................... 30 
14. 
Documentation.............................................................................................. 30 
14.1 Source Documents ....................................................................................... 30 
14.2 Subject Confidentiality .................................................................................. 31 
14.3 Case Report Form Completion ...................................................................... 31 
14.4 Study Summary ............................................................................................ 31 
15. 
Monitoring ..................................................................................................... 31 
15.1 Data Monitoring ............................................................................................ 32 
15.2 Administrative Monitoring .............................................................................. 32 
15.3 Medical Oversight ......................................................................................... 33 
16. 
Publications .................................................................................................. 33 
17. 
Risk Analysis ................................................................................................ 33 
18. 
Records Retention ........................................................................................ 34 
19. 
Termination of the Investigation .................................................................. 35 
20. 
Statistical Methods ....................................................................................... 35 
20.1 Analysis Population ...................................................................................... 35 
20.2 Primary Endpoint .......................................................................................... 35 
20.3 Other Endpoints............................................................................................ 35 
20.4 Sample Size Calculations ............................................................................. 36 
20.5 Interim Reports ............................................................................................. 36 
Appendix A:  Summary of Procedures Required at Each Visit............................... 37 
Appendix B:   Adverse Event and Complaint Reporting Instructions .................... 38 
ATTACHMENT A- SURGEON PREFEReNCE QUESTIONNAIRE (SPQ) ................... 39 
ATTACHMENT B- SURGICAL HANDLEABILITY QUESTIONNAIRE (SHQ).............. 40 
ATTACHMENT C- SURGEON SATISFACTION QUESTIONNARE (SSQ).................. 41 
ATTACHMENT D- SURGEON OVERALL EXPERIENCE QUESTIONNARE (SEQ) ... 42 
 
 
 

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PERSONNEL AND FACILITIES  
SPONSOR 
Johnson and Johnson Surgical Vision, Inc. 
 
1700 E. Saint Andrew Place 
 
Santa Ana, CA 92705 
 
SPONSOR PERSONNEL 
 
 
Medical Monitor: 
  
 
  
 
 
 
 Director, Clinical Science: 
 
 
 
 
 
 
Clinical Research Scientist:  
 
 
 
 
 
 
Study Manager: 
 
 
 
 
                                                      
 
 
Biostatistician: 
  
 
 
 
 
 
 
EMERGENCY TELEPHONE         
  
 
                                
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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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 
1.0, 8.1 
 
 
10.3 
 
 
 
Attachment A 
7, 14 
 
 
19 
 
 
 
38 
Inclusion criterion “Minimum 22 
years of age” 
 
Additional preoperative information 
will may be collected:  
 
 
 
On average how many patients do 
you typically implant have you 
implanted with your preferred toric 
IOL on a monthly basis? 
 
Per IRB recommendation to 
confirm only adults will be 
enrolled in the study. 
Not all of the additional 
preoperative information listed in 
the protocol is required to be 
collected.  
 
Wording modified for clarification. 
 
 
3.0 
1.0, 8.1 
 
 
 
1.0, 8.1 
 
 
 
1.0, 10.1, 
10.3, 10.7 
 
 
10.3 
 
 
10.6 
 
 
10.7 
 
 
11.1 
 
 
 
 
 
 
 
 
 
 
 
Attachment A 
 
7, 14 
 
 
 
8, 15 
 
 
 
9, 17, 
19, 23 
 
 
19 
 
 
21 
 
 
23 
 
 
26 
 
 
 
 
 
 
 
 
 
 
 
38, 39 
 
Inclusion Criteria: Preoperative c 
Corneal astigmatism of one diopter 
or more in the operative eye;  
 
Exclusion Criteria: Planned 
monovision correction (eye 
designated for near vision 
correction); 
 
“Addition of types of preferred toric 
IOLs (monofocal and presbyopia-
correcting)”. 
 
Addition of note: Surgeon may 
choose to use 119.3 or personalized 
A-constant. 
Addition of note: Use of capsular 
tension ring can be used per 
surgeon discretion. 
 
SEQ changed from 3-item to 5-item 
questionnaire 
 
Change to note:  Corneal edema, 
and chronic anterior uveitis/iritis will 
be considered serious if corneal 
edema resulting in BCDVA of 20/40 
or worse at 1 month or later; and 
Grade 1+ uveitis/iritis persists for 
greater than 3 months after surgery). 
Raised IOP requiring treatment 
(Elevation of IOP greater than or 
equal to 10 mmHg above baseline to 
a minimum of 25mmHg) will be 
considered serious if present at the 
last study visit. 
 
Surgeon Preference Questionnaire 
was modified to include 2-items on 
To allow qualified eyes based on 
Optiwave scan measurements to 
be implanted with the study lens. 
 
To allow qualified eye designated 
for distance correction to be 
implanted with the study lens.  
 
 
In order to collect surgeon 
preference of both monofocal 
and presbyopia-correcting toric 
IOLs.  
To allow surgeons to use their 
personalized A-constant. 
 
To allow use of capsular tension 
ring per surgeon discretion. 
 
 
Two additional questions were 
added to the SEQ. 
 
Provide clarification on definition 
of serious adverse events.  
 
 
 
 
 
 
 
 
 
 
Additional data collection. 
 

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Attachment D 
 
 
 
42, 43 
preferred presbyopia-correcting IOL 
and the implant volume. 
 
2-items comparing the rotational 
stability and surgeon confidence 
level in treating astigmatism in 
comparison to preferred presbyopia-
correcting toric IOLs were included 
in the Surgeon experience 
questionnaire. 
 
 
Additional data collection 

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1. 
SYNOPSIS 
PROTOCOL: 
Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC 
II Intraocular Lens (IOL) 
Protocol Number: NXGT-201-TTL2 
STUDY LENS: 
TECNIS® TORIC II - One-Piece Aspheric Acrylic Monofocal 
Posterior Chamber IOL (Model ZCU) 
STUDY OBJECTIVE: 
The purpose of this post-market clinical study is to obtain surgeon 
feedback on the clinical outcomes achieved in the eyes implanted 
with the TECNIS Toric II IOL.  
CLINICAL HYPOTHESIS: 
The overall clinical outcomes of eyes implanted with the TECNIS 
Toric II IOL will be satisfactory to the surgeons.   
STUDY ENDPOINTS: 
Primary Endpoint 
 
Overall surgeon satisfaction of the clinical outcomes assessed by 
a single-item on the Surgeon Satisfaction Questionnaire (SSQ) for 
each eye implanted with the study lens at the 3-month 
postoperative visit.  
 
The percentage of eyes with overall surgeon satisfaction being 
satisfied or very satisfied (defined by a score of 4 or 5) will be 
calculated.   
Other Endpoints 
1. Surgeon responses for a single-item in the Surgical 
Handleability Questionnaire (SHQ) 
2. Surgeon responses for additional items in the Surgeon 
Satisfaction Questionnaire (SSQ) 
3. Surgeon responses for items in the Surgeon Overall 
Experience Questionnaire (SEQ) 
4. The manifest refractive cylinder and spherical equivalent 
as compared to intended  
5. Percent reduction in cylinder 
6. Uncorrected and best corrected distance visual acuities 
7. Medical findings/lens findings/complications/adverse 
events 
OVERALL STUDY DESIGN: 
Structure: 
Prospective, multicenter, single-arm, open-label 
Number of sites: 
Up to 50 sites in the United States  
Duration: 
Three months 

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Indication:  
The TECNIS® Toric II 1-Piece posterior chamber lenses are 
indicated for the visual correction of aphakia and pre-existing 
corneal astigmatism of one diopter or greater in adult patients  
with or without presbyopia in whom a cataractous lens has been 
removed by phacoemulsification and who desire improved 
uncorrected distance vision, reduction in residual refractive 
cylinder, and increased spectacle independence for distance 
vision. The device is intended to be placed in the capsular bag. 
Administration: 
Refractive target outcomes will be emmetropia for each eye. 
Surgeons will perform standardized, small-incision, cataract 
surgery and implant the study lenses using a JJSV-validated 
insertion system qualified for use with TECNIS Toric II lenses as 
specified in the Directions for Use (DFU).  
Visit Schedule: 
Subjects will be implanted with the TECNIS Toric II IOL in one or 
both eyes qualified for study inclusion. Each eye will undergo four 
visits:  Preoperative; Operative; 1-week; and 3-months.   
STUDY POPULATION CHARACTERISTICS: 
Condition: 
Unilateral or bilateral cataract with corneal astigmatism of 
approximately 1.0 to 6.0 D.  
Models ZCU 1.50, 2.25, 3.00, 3.75, 4.50, 5.25. 6.00 
Number of Subjects  
Up to 1100 subjects enrolled with 1,000 subjects treated 
(unilateral or bilateral treatment) 
Inclusion Criteria: 
1. Minimum 22 years of age; 
2. Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior 
chamber IOL implantation have been planned;  
3. Corneal astigmatism of one diopter or more in the operative eye; 
4. Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/30 
Snellen or better; 
5. Clear intraocular media other than cataract in each eye; 
6. Ability to understand, read and write English in order to consent to study 
participation; 
7. Availability, willingness, sufficient cognitive awareness to comply with examination 
procedures; 
8. Signed Informed Consent Document (ICD) and Health Insurance Portability and 
Accountability Act (HIPAA) authorization.   

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Exclusion Criteria: 
1. Recurrent severe anterior or posterior segment inflammation or uveitis; 
2. Compromised eye due to previous trauma or developmental defects in which 
appropriate support of the IOL is not possible; 
3. Circumstances that would result in damage to the endothelium during implantation; 
4. Suspected ocular microbial infection; 
5. 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; 
6. Known ocular disease or pathology that, in the opinion of the investigator, may affect 
visual acuity or require surgical intervention during the course of the study, [macular 
degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), 
uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, 
concomitant severe eye disease, extremely shallow anterior chamber, 
microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic 
nerve atrophy, etc.]; 
7. Planned monovision correction (eye designated for near vision correction); 
8. Concurrent participation or participation within 30 days prior to the preoperative visit 
in any other clinical study. 
NOTE: Physicians considering enrolling a patient with one or more of the conditions listed under 
the warning or precaution in the final approved labeling of the device should weigh the potential 
risk/benefit ratio before enrollment. 
DATA ANALYSIS: 
For questionnaire data, the frequency and proportion with each rating for each item will be 
reported.  For the primary endpoint, these results will also be reported by IOL model for  
lower-cylinder (ZCU150), medium-cylinder (ZCU225 to ZCU375) and extended higher-cylinder 
(ZCU450, ZCU525 and ZCU600) IOLs.  
For visual acuity and refractive data, descriptive statistics will include the mean, standard 
deviation, median, minimum, maximum and 95% confidence intervals.  For visual acuity, the 
frequency and proportion of eyes achieving each acuity line will also be reported. The frequency 
and proportion of eyes within 0.5 D and within 1.0 D of intended values will also be determined 
for postoperative refractive cylinder and spherical equivalent.   
In addition, the frequency and proportion of eyes with medical findings, lens findings, 
complications and adverse events will also be reported. 
STUDY VISITS AND PROCEDURES: 
Subject qualifications will be assessed at the preoperative visit according to the enrollment 
criteria.  The ICD must be signed by any patients who agree to participate in the study prior to 

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undergoing any study-specific procedures. This will include designation as to whether one or 
both eyes are to be included in the study. 
Preoperative Procedures: Following informed consent, demographic, and general 
preoperative information will be collected from routine cataract evaluation examinations.   
Operative Procedures: General operative information and responses from the Surgical 
Handleability Questionnaire (SHQ) will be collected for each implanted eye. 
Postoperative Procedures: At the 1-week visit, uncorrected distance visual acuity (UCDVA), 
medical findings/complications and surgeon satisfaction with rotational lens stability will be 
collected. At the subject’s last study visit (3-month visit), UCDVA, manifest refraction, BCDVA, 
keratometry, and surgeon feedback from the Surgeon Satisfaction Questionnaire (SSQ) will be 
collected.  
At study start (prior to first subject implantation), each surgeons’ preferred toric IOLs (monofocal 
and presbyopia-correcting) and their average implantation volumes on a monthly basis will be 
collected using the Surgeon Preference Questionnaire (SPQ). At the last subject’s 3-month visit 
for each surgeon at each study site, overall surgeon experience with the study lens in 
comparison to their preferred toric IOL (monofocal and presbyopia-correcting) will be collected 
using the Surgeon Experience Questionnaire (SEQ).  
2. 
BACKGROUND/INTRODUCTION 
JJSV has developed a new IOL platform designed to minimize rotation to ≤ 5⁰ within the first 
week after implantation. The TECNIS Toric II 1-Piece lens is an ultraviolet light-absorbing 
posterior chamber intraocular lens (IOL) that compensates for corneal spherical aberrations and 
corneal astigmatism. The benefits of aspheric compensation for corneal spherical aberrations 
are contingent upon full refractive correction of sphere and cylinder. The IOLs incorporate a 
proprietary wavefront-designed toric aspheric optic with a squared posterior optic edge 
designed to provide a 360⁰ barrier. The edge of the optic has a frosted design to reduce 
potential edge glare effects. In addition, compared to the TECNIS Toric 1-Piece IOL, the haptics 
of the TECNIS Toric II 1-Piece IOLs have a squared and frosted design. The anteriorly located 
cylinder axis marks denote the meridian with the lowest power and is to be aligned with the 
steep corneal meridian.  
3. 
CLINICAL HYPOTHESIS 
The overall clinical outcomes of eyes implanted with the TECNIS Toric II IOL will be satisfactory 
to the surgeons.    
4. 
STUDY DESIGN 
This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially 
available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects 
enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US 
study sites.  
5. 
ACRONYMS  
The following acronyms are used throughout the document:  

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• 
AK: astigmatic keratotomy 
• 
BCDVA: best-corrected distance visual acuity 
• 
CRF: case report form 
• 
CRI: corneal relaxing incisions 
• 
D: diopters 
• 
DFU: directions for use 
• 
EDC: electronic data capture 
• 
GCP: good clinical practice 
• 
HIPPA: health insurance portability and accountability act 
• 
ICD: informed consent document 
• 
IOL: intraocular lens 
• 
IOP: intraocular pressure 
• 
IRB: institutional review board 
• 
LASIK: laser-assisted in-situ keratomileusis 
• 
LASEK: laser epithelial keratomileusis 
• 
LRI: limbal relaxing incisions 
• 
OCCI: opposite clear corneal incisions 
• 
OR: operating room 
• 
PRK: photorefractive keratectomy 
• 
SAE: serious adverse events 
• 
SEQ: surgeon experience questionnaire 
• 
SSQ: surgeon satisfaction questionnaire 
• 
SHQ: surgical handleability questionnaire  
• 
UCDVA: uncorrected distance visual acuity 
6. 
STUDY ENDPOINTS 
The purpose of this study is to evaluate the TECNIS Toric II IOL from the perspective of surgical 
handleability, surgeon satisfaction with clinical outcomes and surgeon experience.  
6.1 
PRIMARY ENDPOINT 
Overall surgeon satisfaction of the clinical outcomes achieved in the implanted eye at the  
3-month study visit is assessed based on the question “Please rate your overall level of 
satisfaction with the clinical outcomes achieved in the implanted eye” in Surgeon Satisfaction 
Questionnaire (SSQ). 

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The percentage of eyes with overall surgeon satisfaction being satisfied or very satisfied 
(defined by a score of 4 or 5) will be calculated.   
6.2 
OTHER ENDPOINTS 
1. Surgeon responses for a single-item in the Surgical Handleability Questionnaire 
(SHQ) 
2. Surgeon responses for additional items in the Surgeon Satisfaction Questionnaire 
(SSQ) 
3. Surgeon responses for items in the Surgeon Overall Experience Questionnaire 
(SEQ) 
4. Mean manifest refractive cylinder and spherical equivalent and frequency and 
proportion within 0.5D and 1.0D of intended values 
5. Mean percent reduction in cylinder 
6. Mean uncorrected and best corrected distance visual acuity and frequency and 
proportion within each acuity line 
7. The frequency and proportion of eyes with medical findings/lens 
findings/complications/adverse events/secondary surgical interventions  
7. 
STUDY PRODUCTS 
7.1 
INTRAOCULAR LENS 
The TECNIS Toric II IOL (study lens), Models ZCU150, ZCU225, ZCU300, ZCU375, ZCU450, 
ZCU525, and ZCU600 are posterior chamber, 1-piece, aspheric, hydrophobic acrylic foldable 
IOLs and are to be implanted in the capsular bag following cataract extraction. It is designed to 
minimize the occurrence of large rotations (greater than 10°) following implantation.  
The TECNIS Toric II is a UV light-absorbing posterior chamber lens that compensates for 
corneal spherical aberrations and corneal astigmatism. The benefits of aspheric compensation 
for corneal spherical aberrations are contingent upon full correction of spherical (defocus) and 
cylindrical (astigmatic) refractive error.  
The TECNIS Toric II incorporates an aspheric optic with a squared posterior optic edge 
designed to provide a 360° barrier for reducing the incidence of posterior capsular opacification 
(PCO). The visual benefits of the proprietary wavefront-designed aspheric optic have been 
clinically assessed using the TECNIS® Z9000 IOL (under Investigational Device Exemption 
G960221). As featured in the currently marketed TECNIS Toric (ZCT Series) design, the edge 
of the optic is frosted to reduce potential for edge glare effects.  
The TECNIS Toric II IOLs have two sets of four axis orientation marks 180o apart in the outer 
periphery of the anterior optic surface to indicate the meridian of the lowest power (flat 
meridian).  These axis orientation marks are for proper alignment of the flat meridian of the IOL 
with the steep meridian of the corneal curvature. 
The ZCU150, ZCU225, ZCU300, ZCU375, ZCU450, ZCU525, and ZCU600 lens models are 
intended for cataract patients with pre-existing corneal astigmatism that, when taking surgically 

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8. 
STUDY POPULATION 
All study subjects will be enrolled from the normal surgical cataract population at up to 50 sites 
in the United States. Up to 1100 subjects will be enrolled in the study to achieve 1000 evaluable 
subjects at 3 months. However, data will be collected only for eyes implanted with the study 
lens. This study will include only subjects undergoing primary cataract extraction and IOL 
implantation and who meet all the study enrollment criteria.  All subjects who meet the criteria 
will be offered enrollment in the study.  Enrollment criteria may not be waived by the 
investigator.  Any questions regarding patient eligibility are to be discussed with JJSV prior to 
subject enrollment.  Subjects will be enrolled at each site sequentially until the recruitment goals 
are met. Enrollment will be competitive across sites.  
8.1 
INCLUSION CRITERIA 
1. Minimum 22 years of age; 
2. Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior 
chamber IOL implantation have been planned;  
3. Corneal astigmatism of one diopter or more in the operative eye; 
4. Potential for postoperative best corrected visual acuity (BCDVA) of 20/30 Snellen or 
better; 
5. Clear intraocular media other than cataract in each eye; 
6. Ability to understand, read and write English in order to consent to study 
participation; 
7. Availability, willingness, sufficient cognitive awareness to comply with examination 
procedures; 
8. Signed Informed Consent Document (ICD) and Health Insurance Portability and 
Accountability Act (HIPAA) authorization.   
8.2 
EXCLUSION CRITERIA 
1. Recurrent severe anterior or posterior segment inflammation or uveitis; 
2. Compromised eye due to previous trauma or developmental defects in which 
appropriate support of the IOL is not possible; 
3. Circumstances that would result in damage to the endothelium during implantation; 
4. Suspected ocular microbial infection; 
5. 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 
6. Known ocular disease or pathology that, in the opinion of the investigator, may affect 
visual acuity or require surgical intervention during the course of the study, [macular 
degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), 
uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, 

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concomitant severe eye disease, extremely shallow anterior chamber, 
microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic 
nerve atrophy, etc.]; 
7. Planned monovision correction (eye designated for near vision correction); 
8. Concurrent participation or participation within 30 days prior to the preoperative visit 
in any other clinical study. 
Note: Physicians considering enrolling a patient with one or more of the conditions listed under 
the warning or precaution in the final approved labeling of the device should weigh the potential 
risk/benefit ratio before enrollment. 
9. 
INVESTIGATOR SELECTION 
9.1 
INVESTIGATOR QUALIFICATIONS 
JJSV will select ophthalmic surgeons who have completed a residency in ophthalmology (or its 
documented equivalent) and are licensed to practice medicine and perform surgery at his/her 
investigative site.  Each site will have one designated principal investigator; some sites may 
have additional sub-investigators performing surgery for study cases.   
Investigators will be selected from surgeons who are experienced in small-incision, cataract 
extraction and toric IOL implantation in cataract patients.  Surgeons are defined as 
professionals with experience in handling the surgical products and are familiar with the English 
language.  All communication between the site and the sponsor will be in English.  Additionally, 
surgeons should have established their personalized A-constant for the TECNIS® 1-Piece lens 
platform. 
All sites will be required to have adequate staff support for reporting and patient follow-up, as 
well as the instrumentation necessary to conduct study testing.   
9.2 
INVESTIGATOR OBLIGATIONS 
Investigators are required to fulfill the following obligations: 
• 
Conduct the study in accordance with the relevant and current protocol and all legal 
requirements for clinical trials including ISO 14155 and GCP. Investigator will only make 
changes to a protocol after notifying and obtaining approval from JJSV and the Institutional 
Review Board (IRB) except when necessary to protect the safety, rights or welfare of 
subjects. 
• 
Personally, conduct and supervise the study. 
• 
Maintain a list of appropriately-qualified persons to whom the investigator has delegated 
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. 
• 
Maintain confidentiality as required by HIPAA or similar laws and regulations. 

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• 
Shall not obtain written informed consent from any subject to participate or allow any subject 
to participate before obtaining IRB approval and regulatory approval.  
• 
Document in each subject’s case history that informed consent was obtained prior to 
participation in the study. 
• 
Report to JJSV any adverse experiences that occur during the study in accordance with 
applicable laws and regulations. 
• 
Read and understand the information in the DFU for the study. 
• 
Maintain adequate and accurate records in accordance with applicable laws and regulations 
and make available all study documents and subject medical records for inspection by either 
JJSV, the U.S. Food and Drug Administration, and/or the IRB. 
• 
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.  
• 
Submit progress reports on the investigation to JJSV and the reviewing IRB at regular 
intervals, but no less often than yearly. 
• 
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 study product. 
• 
Provide sufficient accurate financial information to JJSV to allow JJSV to submit complete 
and accurate certification or disclosure statements.  Promptly update this information if any 
relevant changes occur during the investigation or for up to one year following completion of 
the study. 
• 
Comply with all other obligations of clinical investigators and requirements according to all 
United States laws and regulations and all conditions of approval imposed by the reviewing 
IRB. 
• 
Ensure that all associates, colleagues and employees assisting in the conduct of the study 
are adequately informed about the protocol, the study 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 study 
products(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 at the site.  
Copies of IRB submissions and approvals should be forwarded to JJSV.  Study sites will obtain 
IRB approvals and fulfill any other site-specific requirements.  The investigator is required to 

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report to JJSV within five working days any withdrawal of approval by the reviewing IRB for 
his/her participation in the investigation.  
Prior to the start of subject enrollment, the following documents must be signed and returned to 
JJSV: 
• 
Confidentiality Agreement 
• 
Clinical Study Agreement 
• 
Investigator Agreement/Protocol Signature page 
• 
Financial Disclosure form 
• 
Signed and dated copy of investigator’s current curriculum vitae 
• 
Copy of the investigator’s current medical license/number 
• 
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. 
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 U.S. Code of Federal Regulations, the 
Declaration of Helsinki, GCP, ISO 14155 and all other applicable laws and regulations. The 
study will not begin until IRB approvals have been obtained. 
This study will be a prospective, multi-center, open-label, post-marketing clinical study at up to 
50 sites in the United States.  Up to 1100 subjects will be enrolled after informed consent is 
obtained with up to 1000 treated subjects. Subject qualifications will be assessed at the 
preoperative visit according to the enrollment criteria. A subject can have either one eye or both 
eyes enrolled for inclusion in the study.  Each eye will be tracked through the preoperative and 
postoperative schedule individually but only counted as a single subject.   
At study start (prior to first subject implantation), each surgeons’ preferred toric IOL (monofocal 
and presbyopia-correcting) and their average implantation volumes on a monthly basis will be 
collected using the SPQ (Attachment A). 
All subjects will be examined through 3-months postoperatively according to the visit schedule 
described in Section 10.2, Visit Schedule. 
A chart summary of all examination procedures required at each study visit is provided in 
Appendix A. Key preoperative data include visual acuities, manifest refraction, keratometry, 
biometry, and other routine cataract evaluation examinations and response from the SPQ 

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that the subject meets all the required entrance criteria (including lens power determination), the 
subject may be enrolled and scheduled for surgery.  
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 proceed with surgery or 
study participation.  These subjects will be exited from the study.  If the subject has consented 
for both eyes to be included, and one eye screen-fails, the subject continues in the study for the 
other eye. If a subject is being considered for bilateral treatment, only one informed consent 
should be signed.  
Preoperative testing to be performed for each eye includes the following: 
UNCORRECTED DISTANCE VISUAL ACUITY   
Monocular UCDVA is to be measured using a standard Snellen convention. 
BEST CORRECTED DISTANCE VISUAL ACUITY AND MANIFEST REFRACTION  
Preoperative manifest refraction is required. Monocular BCDVA is to be measured using a 
standard Snellen convention.  
KERATOMETRY   
Preoperative corneal astigmatism is to be measured by keratometry or topography.  
IOL POWER AND TARGETED REFRACTION  
Keratometry, axial length and anterior chamber depth (ACD) must be measured to determine 
the appropriate lens power for implantation. Optical biometry methods (i.e., IOLMaster®, 
LENSTAR®) are preferred; however, surgeons should use the biometry method that they have 
the most experience with. The lens power should be calculated to achieve emmetropia at 
distance. The IOL power A-constant used for the TECNIS Toric II is 119.3. The physician should 
determine preoperatively the spherical equivalent and cylindrical power of the lens to be 
implanted.  
NOTE: Surgeon may choose to use 119.3 or personalized A-constant.  
SURGICAL PREFERENCE QUESTIONNAIRE (SPQ)   
Each surgeon will complete a 4-item questionnaire at study start (prior to first subject 
implantation).  The questionnaire will collect information regarding the surgeons’ preferred toric 
IOL (monofocal and presbyopia-correcting) and their average implantation volumes on a 
monthly basis.   
Additional preoperative information may be collected (for each eye included in the study): 
• 
Informed consent documentation  
• 
Subject demographic information  
• 
Planned surgery date(s) 
• 
Ocular history, including presence of ocular pathology 

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• 
Any significant medical findings from a slit-lamp exam, dilated fundus exam, intraocular 
pressure or other. 
10.4 
STUDY LENS SUPPLY 
The Principal Investigator will implant lenses from their TECNIS Toric II inventory. 
10.5 
SELECTION OF THE IOL 
In order to facilitate IOL selection and axis placement, JJSV provides a web-based proprietary 
tool, the TECNIS Toric Calculator (www.TecnisToricCalc.com) for the surgeon. Preoperative 
keratometry and biometry data, incision location, spherical equivalent IOL power, and the 
surgeon’s estimated surgically induced corneal astigmatism are used as inputs for the TECNIS 
Toric Calculator. These inputs are used to determine the axis of placement in the eye and the 
predicted residual refractive astigmatism for TECNIS Toric II 1-Piece IOL models.  
NOTE: The TECNIS Toric Calculator also provides an option for including the Posterior Corneal 
Astigmatism (PCA) (where available). The predetermined value for posterior corneal 
astigmatism can be included in the calculation by checking the box labeled “Include Posterior 
Corneal Astigmatism (PCA)”. 
10.6 
OPERATIVE PROCEDURES 
Surgical procedures should be in accordance with your routine practice and in accordance with 
the labeling.  The surgeons should follow the procedures as described in the DFU for 
appropriate alignment of the IOL axis.  
NOTE: No additional refractive procedures are to be performed during the operative procedure 
or throughout the postoperative study period (e.g., LRI, OCCI, CRI, AK, PRK, LASIK or LASEK). 
NOTE: Optiwave Refractive Analysis (ORA) can be used as a part of routine cataract surgery to 
improve accuracy of the correction.  If ORA is used it will be documented in the Operative case 
report form. 
The Operative case report forms may include the following information: 
INCISION TYPE AND SIZE   
The incision may be clear corneal, limbal or scleral tunnel at the discretion of the investigator. 
Lenses should be inserted per the investigator’s standard technique when using the JJSV-
qualified implantation system. 
CAPSULORHEXIS SIZE AND METHOD  
The anterior capsulotomy should be made per the investigator’s standard technique. The 
anterior capsulotomy method may be manual or laser-assisted.  
LENS REMOVAL 
Lens removal may be performed using phacoemulsification/aspiration only, or through laser-
assisted fragmentation and phacoemulsification/aspiration.  
OPHTHALMIC VISCOSURGICAL DEVICE (OVD)  
OVD materials should be used as is customary for each investigator  

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IMPLANT INSTRUMENTATION USED   
Lenses should be folded for implantation and inserted into the capsular bag using the  
JJSV-qualified implantation system.NOTE: Capsular tension ring can be used per surgeon 
discretion. 
SURGICAL COMPLICATIONS   
Should a surgical complication occur, implantation of a study lens will be at the investigator’s 
discretion. However, in the event of capsular bag or zonular rupture, the study 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 an alternative backup IOL.  
If a subject with one qualifying eye does not receive the study lens due to a surgical 
complication, the subject may be discontinued from the study after resolution of the complication 
to ensure safety. Study-specific postoperative data from this subject will not be collected. If the 
subject has already received a study lens in the first eye, and the second eye does not receive a 
study lens, the subject’s first eye will be followed per the protocol and the second eye will be 
followed to ensure safety, but data will not be reported for that eye. Thus, in this case,  
study-specific postoperative data for the first eye will be collected and study-specific 
postoperative data for the second eye will not be collected. 
MEDICATIONS   
Preoperative, operative and intraoperative medications should be used as is customary for each 
investigator and recorded in the source document for each subject, as appropriate. Only 
medications required for treatment of an SAE will be recorded on the case report forms.  
TYPE OF CLOSURE   
Wound closure is left to the surgeon’s discretion and will be recorded on the case report form. 
SURGICAL HANDLEABILITY QUESTIONNAIRE (SHQ)   
The surgeon will complete a single-item questionnaire at the operative visit for each implanted 
eye. The single-item questionnaire will assess surgeon feedback on the handleability of the 
study lens.   
Additional operative information collected may include: 
• 
Date of surgery 
• 
Operative eye  
• 
Lens power and serial number 
• 
Intended spherical equivalent 
• 
Intended cylinder  
• 
Capsular bag polishing 
• 
Lens placement 
• 
Other surgical procedures 

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• 
Difficulty of lens implantation 
• 
Serious and/or device-related adverse events  
• 
JJSV product complaints 
10.7 
POSTOPERATIVE PROCEDURES  
Postoperatively, subjects will be examined according to the schedule in Section 10.2, Visit 
Schedule. One or both implanted eyes will be examined at 1-week and 3-month visits.  
The postoperative case report form will include the following information, although not all are 
required at every visit:  
UNCORRECTED DISTANCE VISUAL ACUITY   
Monocular UCDVA is to be measured using a standard Snellen convention. 
MANIFEST REFRACTION AND BEST CORRECTED DISTANCE VISUAL ACUITY  
Manifest refraction is to be performed per the site’s usual technique. Monocular BCDVA is to be 
measured using a standard Snellen convention. 
MEDICAL FINDINGS 
At each postoperative visit presence or absence of any medical or lens findings, complications, 
or serious or device-related adverse events will be noted.  
ND:YAG CAPSULOTOMY 
If an Nd:YAG capsulotomy is necessary, it is recommended that the procedure be performed at 
least 1 week prior to a study visit.  
KERATOMETRY AND REFRACTION 
Corneal curvature and refraction are to be measured using the investigator’s usual methods. It 
is recommended that the same methods be used for all study subjects at the site for the 
duration of the study.  

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SURGEON SATISFACTION QUESTIONNAIRE (SSQ)   
This 3-item questionnaire is self-administered and should be completed by the surgeon. The 
purpose of this questionnaire is to collect surgeon satisfaction with the clinical outcomes (e.g., 
rotational stability, uncorrected distance visual acuity) of the eye(s) implanted with the study 
lens.  
Surgeon satisfaction with rotational stability will be collected for each implanted eye using a 
single-item from the SSQ at the 1-week visit. At the 3-month visit, surgeon feedback from the 3-
item SSQ will be collected for each implanted eye.   
SURGEON EXPERIENCE QUESTIONNAIRE (SEQ) 
The surgeon experience questionnaire is a 5-item questionnaire that evaluates the surgeons’ 
overall experience with the study lens in comparison to their historical experience with their 
preferred toric IOL (monofocal and presbyopia-correcting). This questionnaire is self-
administered and should be completed only once after the last follow-up study visit (last 
subject’s 3-month visit) for the study.  
MEDICATIONS   
Postoperative ocular medications should be used as is customary for each investigator and 
recorded in the source document for each subject, as appropriate. Only medications required for 
treatment of an SAE will be recorded on the case report forms.  
ADVERSE EVENTS 
Subjects should be assessed at each visit for the occurrence of and/or change in status of any 
adverse events, particularly serious and/or device-related adverse events. See Section 11, 
Adverse Events, and Error! Reference source not found. for further information. 
10.8 
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. Patients who 
would be traveling, relocating or otherwise unavailable for postoperative follow-up visits should 
not be chosen for this clinical study. 
Subjects will be discontinued from the study if the study lens is removed and the fellow eye 
does not have a study IOL or if the subject dies. 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 uncooperative/refuses further study participation, subject ill/unable to travel.  
A subject will be considered a screen failure if he/she does not meet the enrollment criteria. A 
subject will also be considered a screen failure if he/she does not undergo surgery or receive a 
study lens for various reasons including: the planned implant being aborted due to surgical 
complications, the subject withdrawing consent prior to treatment or the subject died prior to 

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treatment. If a subject receives at least one study lens, he/she is to be followed according to the 
protocol.  
If a subject is exited early from the study, the investigator will submit an Exit Case Report Form 
to JJSV indicating the reason for study exit. In the event of a lens removal or other 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. 
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.  
10.9 
UNSCHEDULED VISITS  
During the study period, if a non-protocol-required visit is done for the purpose of  
medically-indicated follow-up for either study eye, data from this visit should be submitted 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 case report form. 
Data to be collected may include: 
• 
Monocular UCDVA 
• 
Manifest Refraction and monocular BCDVA 
• 
Intraocular pressure 
• 
Medical and/or lens findings, complications  
• 
Serious and/or Device-Related Adverse events 
• 
Ocular Medications 
10.10 PROTOCOL DEVIATIONS  
Any departure from the protocol procedures represents a protocol deviation.  Protocol 
deviations may be subject-based (e.g., enrollment criteria, informed consent deviation, etc.) or 
procedural-based (e.g., out-of-interval visits, non-compliance with testing procedures, etc.).   
Any deviation made to protect the life or physical well-being of a subject in an emergency, as 
well as any use of the study device without obtaining informed consent, must be reported to 
JJSV within 5 working days.   
Protocol deviations will be monitored and managed by JJSV, and if the non-compliance is 
persistent or egregious, JJSV may act, 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  

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11. 
ADVERSE EVENTS AND PRODUCT COMPLAINTS  
11.1 
ADVERSE EVENT 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 event that is believed to be definitely, 
probably or possibly 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 or any malfunction of the device.   
Study-Specific Serious Anticipated Adverse Events 
The following is a list including, but not limited to, ocular serious adverse events that are 
anticipated and must be reported to JJSV for this study.  Any events that are unlikely but 
anticipated (i.e., endophthalmitis or toxic anterior segment syndrome) will be reported to FDA 
and other appropriate regulatory agencies.   
• 
Endophthalmitis/Intraocular infection 
• 
Hypopyon 
• 
Hyphema 
• 
IOL dislocation 

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• 
Cystoid macular edema: Macular edema diagnosed by clinical examination and adjunct 
testing (e.g. OCT, FA) resulting in BCDVA of 20/40 or worse at 1 month or later 
• 
Pupillary block 
• 
Retinal detachment/tear 
• 
Corneal edema 
• 
Chronic iritis or uveitis 
• 
Raised IOP that persists (i.e., is present at the last study visit)  
• 
Toxic anterior segment syndrome (TASS) 
• 
Visual symptoms requiring secondary surgical intervention (e.g., lens removal) 
• 
Tilt, decentration, IOL rotation 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 if corneal 
edema resulting in BCDVA of 20/40 or worse at 1 month or later; and Grade 1+ uveitis/iritis 
persists for greater than 3 months after surgery). Raised IOP requiring treatment (Elevation of 
IOP ≥10 mmHg above baseline to a minimum of 25 mmHg) will be considered serious if present 
at the last study visit. 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse Device 
Effect (USADE) 
Any 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, user 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.  

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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 their reporting 
requirements. If required, adverse events will be reported to the appropriate regulatory agencies 
(e.g., FDA) according to all applicable laws and regulations. Specific instructions on notification 
procedures to JJSV are included in Error! Reference source not found..  
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 
submitting events on the CRF when noted.  Such adverse events are also to be reported to the 
reviewing IRB per their reporting requirements.  
Complaints/Device Deficiency Reporting  
A general product complaint or device deficiency is to be reported to JJSV in a timely manner.  
Notification of complaints/device deficiencies will occur by either submitting 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 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 SAE/ADE 
Detailed Page.  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 48 hours after 
detection).  Any SAE is to be reported by phone (and/or email) and by submitting a completed 
SAE/ADE Detailed Page.  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). 
11.4 
CAUSAL RELATIONSHIP  
The investigator and sub-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 

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initial application of the device).  An attempt should be made by either the investigator or the 
sub-investigator 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 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, 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 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 Unscheduled Visit form 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 and the SAE/ADE form should 
be updated as necessary (e.g., to document the resolution of the SAE/ADE).  Any subject who 
is exited from the study due to a serious and/or device-related adverse 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 by the 

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appropriate regulatory agencies as well as approval of the governing IRB(s) 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 at the site.  
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 must be signed by each study 
subject prior to any study-specific examinations being performed.  The IRB-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 preoperative case report form that a signed agreement of informed 
consent has been obtained and is in the investigator’s possession for each subject.  The site will 
document in the source documents that informed consent was obtained prior to participation in 
the study for each subject enrolled. 
NOTE 1:  The informed consent process also includes obtaining the subject’s signature on an 
Authorization for Use/Disclosure of Health Information for Research Form.  
NOTE 2:  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: 

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• 
Subject’s name and study identification number 
• 
Subject’s contact information   
• 
Study protocol number and the Sponsor name (JJSV)   
• 
A statement that informed consent was obtained prior to participation in the study (including 
the date)  
• 
Dates of all subject visits and surgeries throughout the duration of the study 
• 
Implant serial number identification   
• 
Concomitant medications 
• 
Uncorrected distance visual acuity 
• 
Manifest refraction and best corrected distance visual acuity 
• 
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 
Eyes will be assigned a site/ID number to maintain 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 (EDC).  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 form and related documents.  Prior to database closure, the investigator will verify 
completeness and accuracy of all data collected and submitted to JJSV.  
14.4 
STUDY SUMMARY 
A final investigator’s summary will be provided to JJSV and the reviewing IRB within 3 months 
after termination or the completion of the study or the investigator’s part of the investigation, as 
directed by JJSV.  
15. 
MONITORING  
JJSV will perform three types of monitoring to ensure compliance with regulations: data 
monitoring, administrative monitoring, and safety monitoring. 

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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. 
An EDC system will be used to transmit case report forms from the investigative site to JJSV.  
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, 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 web-based 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 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 JJSV personnel. 
Site Monitoring Plan 
Prior to performing any study implants, the requirements of the study and reporting mechanisms 
will be explained to each investigator during the web-based or on-site training. 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 or have not had a Site Qualification 
Visit in the last 24 months. A study initiation visit will be conducted (either in-person or via a 
web-based meeting) for all sites prior to the first implant.  
Throughout the duration of the study, site visits to monitor compliance to this protocol will be 
made at each site.  During a routine site monitoring visit, 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. Additionally, study logs will be checked to ensure 
compliance with study procedures.  

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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.  
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 
MEDICAL OVERSIGHT 
The medical monitor will be available throughout the clinical trial to review study results and to 
answer any 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 them with the reporting investigator(s) as 
necessary.  The medical monitor, as well as, any other qualified personnel designated by JJSV, 
shall also review study reports. 
16. 
PUBLICATIONS 
Refer to the Clinical Trial Agreement for information regarding JJSV publication policies. 
17. 
RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
RISKS OF THE TECNIS TORIC II INTRAOCULAR LENS 
The acrylic 1-piece IOL TECNIS Toric II is designed to have improved rotational stability relative 
to the currently marketed TECNIS Toric 1-piece IOL (ZCT Series). The lenses are made from 
the same SENSAR soft acrylic material that is used in marketed TECNIS 1-piece lenses. Its 
aspheric anterior surface is intended to compensate for corneal spherical aberration. 
The risk documentation for the currently marketed TECNIS 1-piece lenses, ZCB00 and ZCT 
Series, is applicable. For ZCB00 and ZCT lenses, current risk documentation concludes that all 
risks are identified as low or medium and deemed acceptable.  
An additional risk assessment for the TECNIS Toric II was conducted to analyze potential 
hazardous situations resulting from the design differences compared to the ZCB00 and ZCT 
designs. With the implementation of a Risk Control Plan under this risk assessment, no 
additional safety issues have been identified for the study products for their intended use in the 
proposed clinical investigation. 
GENERAL RISKS OF CATARACT SURGERY AND IOL IMPLANTATION 
There are risks and complications associated with cataract surgery and IOL implantation in 
general. These can include worsening of vision, hemorrhage, loss of corneal clarity, 
inflammation, infections, retinal detachment, pupil changes, glaucoma, etc. Complications can 
result in poor vision, loss of vision or loss of the eye.  
RISK MANAGEMENT 
Subjects will be closely monitored throughout the trial duration. The occurrence of adverse 
events and complaints will be assessed at each study visit and reported to JJSV according to 
Section 11.0, Adverse Events and Product Complaints. Additionally, JJSV will monitor incoming 

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data following the procedures outlined in Section 15.0, Monitoring. The Medical Monitor will 
ensure subjects are not exposed to additional risks by monitoring serious adverse events, 
device-related adverse events, and device-deficiencies that could have led to serious adverse 
events (Section 15.3, Safety Monitoring).  
POTENTIAL BENEFITS 
The general clinical performance of the TECNIS Toric II is expected to be similar to the TECNIS 
Toric ZCT lens series. The primary benefit from implantation of the TECNIS Toric II is the 
correction of astigmatism following removal of the natural crystalline lens due to cataract. 
CONCLUSION 
The hazards/risks associated with the TECNIS Toric II are acceptable and within those of 
JJSV’s currently marketed IOLs. The potential clinical benefits of the TECNIS Toric II IOL 
outweigh the residual risks when the devices are used as intended.  
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 15 years after completion of the study.  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 within the EDC system 
• 
All adverse event information (SAE/ADE detailed pages, follow-up letters, etc.) 
• 
Study supply records/inventory 
• 
IRB and regulatory approval documentation 
• 
Study correspondence  
• 
Study agreements 
• 
Site visit documentation 
• 
Protocol(s) and the reason for any deviations from the protocol 
• 
Subject log(s) 
• 
Completed subject informed consent forms and medical privacy forms (e.g., Authorization 
for Use/Disclosure of Health information)  
• 
Subject medical chart/clinic notes 

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19. 
TERMINATION OF THE INVESTIGATION 
JJSV can suspend or terminate the clinical investigation at any time for reasons it determines 
appropriate.  Additionally, the investigator, or JJSV, may stop a subject’s participation at any 
time.  However, no suspension of the study would be made to disadvantage the study subjects.  
Following suspension of the study for any reason, all study subjects who have already received 
treatment would continue to be followed through completion of the study visit schedule. 
20. 
STATISTICAL METHODS 
This section highlights the analyses to be performed for key study endpoints.  The 3-month 
postoperative visit is the critical analysis time point for the primary endpoint and for other data 
from the SSQ questionnaire, the SEQ questionnaire and for refraction and visual acuity 
endpoints. The operative visit is the key timepoint for evaluation of data from the SHQ 
questionnaire. The one-week visit is the key timepoint for the SSQ question on rotational 
stability. 
Descriptive statistics will typically include mean, standard deviation, median, minimum, 
maximum for continuous data with frequency and proportion reported for categorical data.    
20.1 
ANALYSIS POPULATION 
For the primary endpoint, the primary analysis population will be all eyes implanted with a toric 
IOL (model ZCU150 through ZCU600) and with available data at the 3-month visit. For other 
endpoints, all eyes implanted with a toric IOL model ZCU150 to ZCU600 and with available data 
at the key timepoint for that endpoint will be used. In addition, data for the primary endpoint will 
also be evaluated by IOL model for lower-cylinder IOLs (ZCU150), medium-cylinder IOLs 
(ZCU225 to ZCU375) and for extended higher-cylinder IOLs (ZCU450, ZCU525 and ZCU600). 
For the surgeon preference questionnaire (SPQ) and the surgeon experience questionnaire 
(SEQ), the analysis population will be surgeons responding to these questionnaires. 
20.2 
PRIMARY ENDPOINT 
The primary endpoint for this study is the response to a single-item evaluating the surgeon’s 
rating of overall level of satisfaction with the clinical outcome for each eye from the SSQ. 
Surgeon satisfaction is defined as having a score of 4 (satisfied) or 5 (very satisfied).  The 
frequency and proportion of eyes with a rating of 4 or 5 and the 95% confidence interval for this 
proportion will be reported.   In addition, the frequency and proportion with each response will 
be tabulated for this item.  
20.3 
OTHER ENDPOINTS 
For other items on the SSQ, the frequency and proportion of eyes with each response will be 
reported for the individual items on the questionnaire. The frequency and proportion of eyes will 
be reported for the single-item on the SHQ. For the SEQ and the SPQ, the frequency and 
proportion of surgeons with each response will be reported. 
Descriptive statistics for all eyes will be reported for mean refractive cylinder, cylinder vs 
intended cylinder, spherical equivalent and spherical equivalent vs intended and f or percent 
reduction in cylinder. In addition, the frequency and proportion of eyes within 0.50 D and within 
1.00 D of intended values will be reported for refractive cylinder and spherical equivalent.  

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For visual acuity, the values will be converted to logMAR prior to analysis. Descriptive statistics 
for all eyes will be reported for mean logMAR monocular uncorrected and best corrected 
distance visual acuity. The frequency and proportion of eyes achieving each acuity line will also 
be reported for uncorrected and best corrected distance visual acuity.   
Enrollment data, demographic data, accountability data and operative complications/ 
procedures will be reported using descriptive statistics.  
The frequency and proportion of eyes with medical/lens findings or adverse events will also be 
reported.   
20.4 
SAMPLE SIZE CALCULATIONS 
With a minimum of 1000 eyes, the two-sided 95% confidence interval for the proportion of eyes 
rated as having acceptable performance will extend within 1.4% from the observed proportion 
assuming an expected overall satisfactory proportion of 95%. 
20.5 
INTERIM REPORTS 
Interim study progress reports may be conducted during the study. 
 
 
 
 
 
 

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APPENDIX A:  SUMMARY OF PROCEDURES REQUIRED AT EACH VISIT 
  
 
Examination 
Preop 
(Visit 1) 
Op 
(Visit 2) 
1-week 
(Visit 3) 
3-month 
(Visit 4) 
Informed consent, ocular history, enrollment 
criteria, IOL power calculations 
+ 
 
 
 
Biometry  
+ 
 
 
 
Keratometry 
+ 
 
 
+ 
Lens power/serial number 
 
+ 
 
 
Surgeon Preference Questionnaire (SPQ) 
+a 
 
 
 
Surgical Handleability Questionnaire (SHQ) 
 
+b 
 
 
UCDVA 
+ 
 
+ 
+ 
Manifest refraction 
+ 
 
 
+ 
BCDVA 
+ 
 
 
+ 
Medical findings/lens 
findings/complications/adverse events 
+ 
 
+ 
+ 
Surgeon satisfaction with rotational lens 
stability (Single-item from SSQ) 
 
 
+ 
 
Surgeon Satisfaction Questionnaire (SSQ) 
 
 
 
+ 
Surgeon Experience Questionnaire (SEQ) 
 
 
 
+c 
 
a At study start (prior to first subject implantation) 
b At the operative visit for each implanted eye 
c At the last subject’s 3-month visit for each surgeon at each study site 

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

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ATTACHMENT A- SURGEON PREFERENCE QUESTIONNAIRE (SPQ) 
Instructions 
• 
This questionnaire is self-administered and should be completed by the surgeon 
prior to the first subject being implanted in the study.  
• 
The purpose of this questionnaire is to collect your preferred toric IOL and its 
implantation volume.  
 
1) Please specify your choice for preferred monofocal toric IOL (choose one). 
 
 
 
 
 
 
 
2) Please specify your choice for preferred presbyopia-correcting toric IOL (choose 
one). 
 
 
 
 
 
 
 
 
 
3) On average how many patients do you typically implant with your preferred 
monofocal toric IOL on a monthly basis? 
 
Less than 5 
☐ 
5 to 10 
☐ 
11 to 15  
☐ 
More than 15  
☐ 
Other, Specify _______________________________ 
☐ 
 
4) On average how many patients do you typically implant with your preferred 
presbyopia-correcting toric IOL on a monthly basis? 
 
Less than 5 
☐ 
5 to 10 
☐ 
11 to 15  
☐ 
More than 15  
☐ 
Other, Specify _______________________________ 
☐ 
 
 
 
TECNIS® Monofocal Toric 
☐ 
AcrySof® IQ Toric 
☐ 
enVista Toric 
☐ 
Other, Specify _______________________________ 
☐ 
TECNIS Symfony® Toric 
☐ 
AcrySof® IQ ReSTOR®     
☐ 
AcrySof® IQ PanOptix® 
☐ 
Trulign Toric 
☐ 
Other, Specify _______________________________ 
☐ 

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ATTACHMENT B- SURGICAL HANDLEABILITY QUESTIONNAIRE (SHQ) 
Instructions 
• 
This questionnaire is self-administered and should be completed by the 
surgeon following the completion of the surgery for each eye.  
• 
The purpose of this questionnaire is to collect surgeon feedback on the 
handleability of the TECNIS® Toric II IOL (study lens).  
 
 
Rate your level of confidence in controlling the position of the study lens in the 
implanted eye?  
 
       
5- Extremely confident 
☐ 
4- Quite a bit confident 
☐ 
3- Somewhat confident  
☐ 
2- A little confident  
☐ 
1- Not at all confident 
☐ 
       
           
If you answered “1-Not at all confident” or “2- A little confident”, please specify 
reason. 
 
________________________________________________________________ 
 
 

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ATTACHMENT C- SURGEON SATISFACTION QUESTIONNARE (SSQ) 
Instructions 
• 
This questionnaire is self-administered and should be completed following the 
completion of the last study visit (3-month visit) for each eye separately.  
• 
The purpose of this questionnaire is to collect your feedback on the clinical 
outcomes achieved in each eye implanted with the TECNIS® Toric II IOL (study 
lens).  
 
1) Please rate your overall level of satisfaction with the clinical outcomes achieved 
in the implanted eye.  
 
5- Very satisfied 
☐ 
4- Satisfied 
☐ 
3- Undecided  
☐ 
2- Dissatisfied 
☐ 
1- Very dissatisfied 
☐ 
 
If you marked “1- Very dissatisfied” or “2- Dissatisfied”, please specify reason. 
 
________________________________________________________________ 
 
2) Please rate your level of satisfaction with the rotational stability of the study lens 
in the implanted eye. 
 
5- Very satisfied 
☐ 
4- Satisfied 
☐ 
3- Undecided  
☐ 
2- Dissatisfied 
☐ 
1- Very dissatisfied 
☐ 
 
If you marked “1- Very dissatisfied” or “2- Dissatisfied”, please specify reason. 
 
________________________________________________________________ 
 
 
 
3) Please rate your level of satisfaction with the achieved uncorrected distance 
visual acuity in the implanted eye. 
 
5- Very satisfied 
☐ 
4- Satisfied 
☐ 
3- Undecided  
☐ 
2- Dissatisfied 
☐ 
1- Very dissatisfied 
☐ 
 
If you marked “1- Very dissatisfied” or “2- Dissatisfied”, please specify reason. 
 
________________________________________________________________ 

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ATTACHMENT D- SURGEON OVERALL EXPERIENCE QUESTIONNARE (SEQ) 
Instructions 
• 
This questionnaire is self-administered and should be completed after the last 
subject’s 3-month visit for each surgeon at your site. 
• 
Please answer the questions based on your overall experience with your 
preferred toric IOL prior to the study vs. TECNIS® Toric II IOL (study lens).   
 
1. How is the rotational stability of the study lens in comparison to your preferred 
monofocal toric IOL used prior to the study?  
        
5- Much better 
☐ 
4- Somewhat better 
☐ 
3- Same  
☐ 
2- Somewhat worse  
☐ 
1- Much worse 
☐ 
 
If you answered “1- Much worse” or “2- Somewhat worse”, please specify 
reason.  
 ________________________________________________________________ 
 
2. How is the rotational stability of the study lens in comparison to your preferred 
presbyopia-correcting toric IOL used prior to the study?  
        
5- Much better 
☐ 
4- Somewhat better 
☐ 
3- Same  
☐ 
2- Somewhat worse  
☐ 
1- Much worse 
☐ 
 
If you answered “1- Much worse” or “2- Somewhat worse”, please specify 
reason.  
 ________________________________________________________________ 
 
 
3. Rate your level of confidence in treating astigmatism with the study lens in 
comparison to your preferred monofocal toric IOL used prior to the study? 
 
5- Much more confident 
☐ 
4- Somewhat more confident 
☐ 
3- Same  
☐ 
2- Somewhat less confident  
☐ 
1- Much less confident 
☐ 
 
If you answered “1-Much less confident” or “2- Somewhat less confident”, please 
specify reason 
________________________________________________________________ 

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4. Rate your level of confidence in treating astigmatism with the study lens in 
comparison to your preferred presbyopia-correcting toric IOL used prior to the 
study? 
 
5- Much more confident 
☐ 
4- Somewhat more confident 
☐ 
3- Same  
☐ 
2- Somewhat less confident  
☐ 
1- Much less confident 
☐ 
 
If you answered “1-Much less confident” or “2- Somewhat less confident”, please 
specify reason 
________________________________________________________________ 
 
 
5. Would you recommend the study lens to your fellow surgeons? 
   
3- Yes 
☐ 
2- Maybe 
☐ 
1- No 
☐ 
      
If you answered “1- No” or “2- Maybe”, please specify reason.  
 
_______________________________________________________________