A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System
Phase: NA
Conditions: Cataract
Sponsor: Mynosys Cellular Devices, Inc.

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A PROSPECTIVE MULTI-CENTER STUDY OF ANTERIOR LENS 
CAPSULOTOMY USING THE MYNOSYS ZEPTOTM SYSTEM 
 
 
 
 
 
  
 
 
 
 
IDE PROTOCOL: MYN-002 
  
STUDY SPONSOR: 
MYNOSYS CELLULAR DEVICES, INC. 
46710 Fremont Blvd 
Fremont CA 94538-6538 
(510) 857-6296 
 
Revision A 
Revision Date:  July 06, 2016 
 
 
I have read and agree to follow the study procedures as outlined in this protocol. 
 
 
 
 
 
 
 
______________ 
  Print Name of Investigator 
 
 
 
 
 
 
______________ 
 
 
 
____________ 
   Investigator’s Signature 
 
 
          
Date 
 
This protocol contains confidential proprietary information with respect to the ZeptoTM System 
and clinical trials of this product.  I agree to hold this information in confidence and not to 
disclose it to any third parties for a period of (3) years from the date of this agreement, or until 
said information shall become a matter of public knowledge or until a formal written agreement 
for that purpose has been entered into by the parties 
 
 
 
 
 
 
______________ 
 
 
 
_____________ 
   Investigator’s Signature 
 
 
          
Date 

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Table of Contents 
  Page  
I. PERSONNEL AND FACILITIES .....................................................................................4  
II. INTRODUCTION AND RATIONALE ...........................................................................5  
III. PRE-CLINICAL TESTING.............................................................................................5  
IV. REPORT OF PRIOR INVESTIGATIONS.....................................................................6  
V. STUDY OBJECTIVES ......................................................................................................7  
VI. PARAMETERS .................................................................................................................7 
A. Effectiveness Parameter.........................................................................................7  
B. Safety Parameter ....................................................................................................7 
C. Other Parameters To Be Captured………………………………………….......8  
VII. STUDY DESIGN .............................................................................................................8 
VIII. SUBJECT POPULATION............................................................................................9  
A. Inclusion Criteria...................................................................................................9  
B. Exclusion Criteria ..................................................................................................9  
IX. STUDY MATERIALS AND METHODS ......................................................................10  
A. Subject Entry..........................................................................................................10  
B. Clinical Parameters ...............................................................................................10  
C. Examination Schedule ..........................................................................................11  
D. Description of Device ............................................................................................11  
E. ZeptoTM Capsulotomy Procedure ........................................................................12  
F. Postoperative Care.................................................................................................13  
G. Data Reporting......................................................................................................14  
H. Study Completion Procedures ............................................................................14  
X. COMPLICATION AND ADVERSE EVENT REPORTING.......................................14  
A. Definitions..............................................................................................................15  
B. Identification and Collection................................................................................16  
C. Evaluation..............................................................................................................17  
D. Reporting ..............................................................................................................18  
E. Adverse Event Reporting Matrix .......................................................................19  
F. Adverse Events (AEs) and Serious Adverse Events (SAEs) at Subject Exit…19  
XI. SAMPLE SIZE ................................................................................................................20  
XII. DATA ANALYSIS ………….........................................................................................20  

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XIII. STUDY MONITORING...............................................................................................20 
 
XIV.  APPENDICES...............................................................................................................22  
Appendix 1: Proposed Informed Consent Form......................................................22  
Appendix 2: Schedule of Visits and Clinical Parameters........................................30  
Appendix 3: Methods of Clinical Evaluation………………………………..…..…31 
Appendix 4: Sponsor’s Commitments ......................................................................32  
Appendix 5: Investigator’s Qualifications and Responsibilities..............................33  
Appendix 6: Investigator Agreement ........................................................................34  
Appendix 7: Declaration of Helsinki………………………………..........................37  
Appendix 8: References...............................................................................................39 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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I. 
PERSONNEL AND FACILITIES 
 
 
 
Sponsor: 
 
 
Mynosys Cellular Devices, Inc. 
 
 
 
 
46710 Fremont Blvd 94538-6538 
 
 
Sponsor Clinical  
 
Dan Marinsik 
Representative: 
 
Mynosys Cellular Devices, Inc. 
 
 
 
 
46710 Fremont Blvd 94538-6538 
 
 
 
 
Phone: 510-857-6296 FAX: 510-689-2349 
 
 
Medical Monitor: 
 
Kevin L. Waltz, O.D., M.D. 
 
 
 
 
8103 Clearvista Parkway, Suite 240 
 
 
 
 
Indianapolis, IN  46256 
 
 
 
 
  
 
Investigator(s): 
 
William Christie, M.D. 
 
 
 
 
 
 
1101 Freeport Rd  
Pittsburgh, PA 15238  
  
 
Daniel H. Chang, M.D. 
4101 Empire Drive, Suite 120 
Bakersfield, CA 93309 
  
 
 
 
 
 
David F. Chang, M.D. 
 
 
 
 
 
 
Peninsula Eye Surgery Center 
 
 
 
 
1128 W. El Camino Real 
 
 
 
 
 
 
 
 
Mountain View, CA 94040 
  
 
 
 
 
 
Eric D. Donnenfeld, M.D. 
 
 
 
 
 
 
711 Stewart Ave #160,  
 
 
 
 
Garden City, NY 11530 
  
 
Phillip C. Hoopes, M.D. 
11820 S. State St. 
Draper, UT 84020  
  
 
 
 
 
 
John Vukich, M.D. 
 
 
 
 
 
 
1025 Regent St  

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Madison, WI 53715 
 
 
 
 
Farrell C. Tyson II, M.D. 
 
 
 
 
 
 
4120 Del Prado Blvd.,  
 
 
 
 
Cape Coral, FL 33904 
  
 
 
 
 
 
Vance Thompson, M.D. 
 
 
 
 
 
 
 
3101 W. 57th St.,  
 
 
 
 
Sioux Falls, SD 57108 
  
 
II. 
INTRODUCTION AND RATIONALE 
 
 
The Mynosys ZeptoTM System (“ZeptoTM”) is a surgical instrument for intervention in the eye 
based on the use of short energy pulses to create the rapid phase transition of water molecules in 
or near tissues to create a tissue cutting force.  The same fundamental mechanism of action is 
found in other approved devices for anterior lens capsulotomy such as the FugoBlade and the 
femtosecond laser. 
 
Lens cataract surgery with phacoemulsification is the standard of care for the treatment of 
symptomatic lens cataract.  A critical step in cataract surgery is anterior lens capsulotomy in 
which a circular opening is created in the capsule that surrounds the diseased lens.  This opening 
allows the lens material to be removed safely from the eye via phacoemulsification, and an 
intraocular lens (IOL) to be implanted within the capsular bag.    
 
ZeptoTM provides a means to create capsulotomy openings that are consistent in shape and size. 
 
This clinical study is being undertaken to demonstrate the effectiveness and safety of ZeptoTM as 
a surgical instrument for performing anterior lens capsulotomies in subjects undergoing cataract 
surgery with phacoemulsification.   
 
 
 
III.  PRE-CLINICAL TESTING 
 
All of the following pre-clinical test results have been peer-reviewed and published 1. 
 
 
1) Ocular Condition After ZeptoTM Capsulotomy	  
 
A GLP study was conducted in twenty rabbits in which one eye received a ZeptoTM 
capsulotomy and the other eye, a continuous curvilinear capsulorhexis (CCC), both followed 
by lens phacoemulsification and IOL implantation.  No differences were noted in ocular 
condition and recovery between either groups at 1 day, 3 days, 1 week and 4 weeks after 
surgery.  No difference in inflammation was observed between the two groups from gross or 
microscopic pathology examination.  	  

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2) Anterior Chamber Temperature Changes 
 
Temperature changes were recorded using thermocouples in the anterior chamber during 
ZeptoTM capsulotomies in living rabbit eyes.  Temperature changes of 1-2oC were measured 
for 2-4 seconds directly adjacent to the ZeptoTM suction cup and at the corneal endothelium 
closest to the ZeptoTM suction cup.  Both the magnitude and duration of these temperature 
changes were significantly below the thresholds required for cellular damage 2. 
 
3) Corneal Endothelial Cell Condition 
 
The corneal endothelium was examined as part of the GLP study and no differences were 
found in corneal endothelial cell damage between eyes that received a ZeptoTM capsulotomy 
versus a CCC.    
 
	  
IV. 
REPORT OF PRIOR INVESTIGATIONS 
 
The Mynosys ZeptoTM System has been used in human clinical studies in San Salvador, El 
Salvador with approval by the government of El Salvador. 
 
In the first study, 10 subjects with symptomatic age-related lens cataract received ZeptoTM 
capsulotomies during cataract surgery with phacoemulsification and implantation of a foldable 
one-piece acrylic IOL. All 10 ZeptoTM capsulotomies resulted in complete 360o capsule openings 
with free-floating capsule buttons. All 10 subjects received intracapsular IOL fixation. All 
subjects reported good vision at one-week and at 30-days post procedure. 
 
A second study of 10 subjects was undertaken to investigate a slightly smaller suction cup and 
ring combination, with all other aspects of the ZeptoTM capsulotomy system remaining the same. 
ZeptoTM capsulotomies in the first 4 subjects resulted in some tissue bridges causing the capsule 
button to remain attached to the capsule.  These capsulotomies were completed manually using 
forceps.  All 4 subjects underwent successful phacoemulsification with intracapsular IOL 
fixation.  The cause of these incomplete capsulotomies with remaining tissue bridges was traced 
to a small suction leak in the handpiece that reduced the delivery of suction to the suction cup 
and affected ZeptoTM’s performance.  The study was stopped and the remaining 6 subjects 
underwent manual CCC, phacoemulsification, and IOL implantation.  The sponsor identified an 
incorrect setting on the ZeptoTM handpiece leak tester at the contract manufacturer that resulted 
in the leaks not being identified during production.  This problem has now been resolved.  
 
A third study was conducted in 10 subjects to investigate using the introduction of BSS 
following ZeptoTM capsulotomy as a means to separate the capsule button off the roof of the 
suction cup, and at the same time float off the suction cup from the capsule.  In addition, the last 
5 subjects received a slightly longer duration of suction to create apposition of the nitinol ring 
against the capsule.   In these 5 cases, suction was maintained until the surgeon verified visually 
that small bubbles in the OVD ceased movement, indicating full suction.  All 10 subjects that 
received ZeptoTM capsulotomies had complete capsulotomies with a capsule button separated 

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from the suction cup and remaining in the anterior chamber.  All underwent successful 
phacoemulsification with intracapsular IOL fixation.  Eight out of the 10 subjects returned for 
follow up at 4 weeks.  There were no adverse clinical findings and no capsule related problems.  
All 10 ZeptoTM capsulotomies were successful, and visual confirmation of full suction provided 
assurance of capsulotomy completion. 
 
A fourth study of 10 subjects was undertaken to re-confirm the effectiveness of the BSS float-off 
mechanism to separate the capsule button from the suction cup and to float-off the suction cup 
from the capsule.  In all cases, the surgeon was also instructed to wait for visual confirmation of 
cessation in OVD movement prior to initiating ZeptoTM capsulotomy.  All 10 ZeptoTM 
capsulotomies resulted in complete round capsule openings with no residual tissue bridges. All 
10 capsule buttons were free floating and easily identified and retrieved by the surgeon.  All 10 
subjects underwent successful phacoemulsification with intracapsular IOL fixation. 
 
 
V. 
STUDY OBJECTIVE 
 
This study will evaluate outcome in subjects who have elected to have ZeptoTM capsulotomies 
during cataract surgery with phacoemulsification. 
 
 
VI.  
PARAMETERS 
 
A. 
Primary Effectiveness Endpoint - Complete Capsulotomy (At least 95% of cases) 
 
Clinical Discussion - In clinical practice, a successful capsulotomy results in a rounded, 
anterior capsular opening through which the cataract can be extracted. The capsulotomy 
preserves a bag-like configuration of the remaining lens capsule, which enables secure 
intracapsular fixation of the IOL.  
 
A successful complete ZeptoTM capsulotomy is defined in this protocol to be one that 
results in a complete 360o capsulotomy without any residual tissue bridges visible to the 
surgeon. If there are such tissue bridges, the surgeon completes the capsulotomy 
manually.   
 
Effectiveness Rate – An effectiveness rate of 95% complete capsulotomies provides 
reasonable assurance that the ZeptoTM system is effective. 
 
Data Recording - The presence of a complete capsulotomy without tissue bridges will be 
recorded by the surgeon as a Yes or No following each ZeptoTM capsulotomy. 
 
 
B.        Primary Safety Endpoint - Posterior Capsular Rupture & Vitreous Loss (4% or 
less) 
Clinical Discussion - Posterior capsular rupture & vitreous loss is generally considered 
one of the most significant complications of cataract surgery that occurs with some 
frequency.  One well recognized cause is posterior extension of an anterior capsular 
radial tear. It is noteworthy however, that the majority of anterior capsular tears do not 

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adversely impact visual outcome.3   Posterior capsular rupture and vitreous loss subject 
the patient to additional risks of postoperative complications commonly resulting in 
suboptimal best corrected visual acuity, and usually precludes intracapsular IOL fixation. 
Due to its potential adverse impact on best corrected visual acuity, posterior capsular 
rupture and vitreous loss related to ZeptoTM capsulotomy is chosen as the primary safety 
endpoint. 
 
Posterior Capsule Rupture & Vitreous Loss Rate – The incidence of posterior 
capsular rupture and vitreous loss has been documented in 13 peer-reviewed publications 
over the period between 1999-2011.  With one exception, all of these studies have shown 
rates ranging from 1.1 to 4.4 percent depending on surgeon group 4-16.  A posterior 
capsular rupture and vitreous loss rate within the range of this published data in subjects 
receiving ZeptoTM capsulotomies will provide reasonable assurance that the ZeptoTM 
capsulotomy system acceptably meets the safety endpoint in the proposed study. 
 
Data Recording – The occurrence of a posterior capsular rupture and vitreous loss will 
be recorded by the surgeon as a Yes or No following the completion of surgery. 
 
 
C. 
Other Parameters To Be Captured 
 
1) Anterior Capsule Tear  – The occurrence of an anterior capsule tear will be recorded 
by the surgeon as a Yes or No after the completion of ZeptoTM capsulotomy.  
 
2) Corneal Touch  - The occurrence of corneal touch by the ZeptoTM capsulotomy tip 
during its use will be recorded by the surgeon as a Yes or No after the completion of 
ZeptoTM capsulotomy. 
3) Capsulotomy Diameter – The diameter of the ZeptoTM capsulotomy will be measured 
during surgery by the surgeon using an intraocular rhexis ruler.    
 
VII. 
STUDY DESIGN 
This study is a prospective, non-randomized, multi-site clinical study with up to 8 clinical sites 
enrolling a total of 100 eyes of subjects aged 22 and older, who will have ZeptoTM capsulotomy 
followed by conventional phacoemulsification and IOL implantation. 
 
Subjects will be screened for eligibility and informed consent will be obtained from those who 
meet screening criteria and are interested in participation in the study. Eligible subjects will be 
examined preoperatively to obtain a medical history and to establish a baseline for ocular 
condition. Baseline measurements will be collected as outlined in Section IX. 
 
 
 

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VIII. SUBJECT POPULATION 
 
Subjects with symptomatic age-related lens cataract desiring lens extraction and IOL implantation. 
 
 
A. 
INCLUSION CRITERIA 
 
1. Subjects must be age 22 or older, 
2. Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the 
treatment of symptomatic age related lens cataract, and then electing to undergo ZeptoTM 
capsulotomy, 
3. Subjects must be willing and able to return for scheduled treatment and follow-up 
examinations for 1 month. 
 
 
B. 
EXCLUSION CRITERIA 
 
1. Disease or pathology in the treatment eye that will compromise visual performance or 
refractive outcome (e.g. previous refractive surgery), 
2. Zonular abnormality,  
3. Posterior polar cataract, 
4. Fellow eye with acuity less than 20/200,  
5. Any prior ocular surgery of the study eye, 
6. Advanced glaucoma (greater than 0.8 cup: disk) or intraocular pressure ≥ 30 mmHg in the 
study eye, 
7. Pupillary dilation during the pre-operative exam of less than 7 mm in diameter, 
8. Proliferative diabetic retinopathy, 
9. Disorders of the ocular muscles, such as nystagmus or strabismus,  
10. Chronic uveitis, 
11. Abnormal corneal endothelium, 
12. Subjects on medications with, in the opinion of the surgeon, significant ocular side effects, 
13. Pregnant or nursing (lactating) women, 
14. Implanted ocular device or drug in the study eye, 
15. Any other condition, which in the judgment of the investigator would prevent the subject 
from completing the study (e.g. documented diagnosis or treatment for symptoms associated 
with dementia, mental illness), 
16. Current participation in another drug or device clinical study, or participation in such a 
clinical study within the six months. 
 
 
 
 
 

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IX. 
STUDY MATERIALS AND METHODS 
 
A. 
SUBJECT ENTRY 
 
The investigator will identify potential subjects for this study based on routine ocular 
examination of the investigator’s patients. No study specific procedures will be conducted prior 
to obtaining informed consent from the subject. The investigator or qualified site personnel will 
explain the study purpose, procedures, and subject responsibilities to the potential participant. 
The subject's willingness and ability to meet the follow-up requirements will be determined. The 
investigator or his/her designee will answer all pertinent questions asked by the subject. When it 
has been established that the subject is likely to be eligible for participation, written informed 
consent will be obtained. The subject will sign and date the informed consent form in the 
presence of a witness. The investigator will also sign and date the consent form. One copy of the 
informed consent form will be retained with the subject records and a copy will be provided to 
the subject. The consent process will be documented in a brief medical note in the subject’s 
source file.  
 
After the subject has signed the consent form, the subject will be assigned a subject ID number 
for the study. Once a subject has been consented, he/she will only be identified with his/her 
personal ID number and name initials. All other identification data will be held confidential.  
 
Once the subject has been consented, the subject may undergo study specific procedures, 
including surgery with the ZeptoTM capsulotomy surgery. Baseline examination will be 
performed no more than 2 weeks prior to ZeptoTM capsulotomy surgery. After the baseline 
examination, if the subject meets the inclusion and exclusion criteria, the subject will be 
scheduled for cataract surgery with ZeptoTM capsulotomy.  
 
For subjects with bilateral cataracts and who meet all inclusion and exclusion criteria in both 
eyes, only one eye will be selected for ZeptoTM capsulotomy.  This study eye will be chosen 
randomly by drawing left eye / right eye ballots. 
 
Only subjects discontinued prior to ZeptoTM capsulotomy may be replaced in the study. Those 
subjects who are enrolled to replace withdrawn subjects will receive new ID numbers.  
 
 
B. 
CLINICAL PARAMETERS 
 
The following list of clinical parameters is typically collected as part of routine pre-operative 
testing.  If they are not collected as part of the routine pre-operative examination, they will be 
collected as study specific procedures prior to cataract surgery.   
  
1. Manifest refraction  
2. Uncorrected distance visual acuity (UCVA) 
3. Best spectacle corrected distance visual acuity (BSCVA)  
4. Dilated pupil size 
5. Slit lamp and fundus examination   

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C. 
EXAMINATION SCHEDULE 
 
Subjects enrolled in the study will be required to commit to the following examination schedule and 
take part in the clinical evaluations as outlined in Appendix 2. 
 
Preoperative Evaluation         (Day -14 to Day -1) 
Operative Evaluation   
(Day 0) 
Day 1              
 
(1 to 2 days postoperative) 
Week 1 
             
(5 to 12 days postoperative)   
Month 1 
 
 
(3 to 6 weeks postoperative) 
 
 
D. 
DESCRIPTION OF DEVICE 
 
The Mynosys ZeptoTM System consists of a disposable surgical handpiece (104mm x 22mm 
(4.14” x 0.866”) that is operated by the surgeon to perform the capsulotomy and which is 
connected to a small table-top control console  (10”w x 14”d x 7”h) located within the surgical 
suite (see Figure 1). In use, the surgeon holds the device in a horizontal grip. The functional 
portion used for capsulotomy is the capsulotomy tip located at the front end of the handpiece and 
consists of a circular, soft silicone suction cup 1.18 mm in height and 6.10 mm in diameter. This 
silicone suction cup houses a nitinol ring that delivers the energy pulses to create the 
capsulotomy.  The capsulotomy handpiece is connected to the console containing suction 
controls, electronic timing circuits, safety diagnostics, and an audio interface.   
 
A ZeptoTM capsulotomy is performed by applying suction to the suction cup causing the nitinol 
ring to be apposed to the lens capsule.  A series of 12 electrical pulses lasting a total of 4 
milliseconds is delivered to the nitinol ring causing rapid phase transition of water molecules 
trapped between the bottom edge of the nitinol ring and the capsule.  The rapid volume 
expansion results in the capsule cutting action.  Suction is then vented to atmosphere. The 
operating assistant will, upon command from the physician, introduce a small amount of 
Balanced Salt Solution (BSS) into the suction cup to allow for a gentle release of the suction cup 
from the capsule, and to allow the free-floating capsule button to stay behind in the anterior 
chamber for manual removal with forceps.  Upon completion of the capsulotomy, the disposable 
ZeptoTM Handpiece tip is removed from the eye.  

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E. 
ZEPTOTM CAPSULOTOMY PROCEDURE 
 
The ZeptoTM capsulotomy will be performed on Day 0 of the study according to the following 
instructions: 
 
1. Patient Preparation	  
1.1. Obtain preoperative dilation per standard protocol. 
1.2. Obtain anaesthesia per standard protocol. 
1.3. Clean the subject’s eyelids and ocular adnexa with disinfecting solution.  
1.4. Apply sterile drapes. 
 
2. ZeptoTM System Setup 
2.1. Ensure that the red ‘Emergency Off’ button is in the ‘Out’ position. 
2.2. Plug the female end of the Zepto™ Power Cord into the rear of the Zepto™ Power 
Console, and then plug the male end of the power cord into a properly grounded 
electrical outlet.  
2.3. Make sure the area around the electrical outlet is clear and easily accessible, in case 
there is a need to unplug the Zepto™ Power Console from the outlet. 
2.4. Make sure that the electrical outlet that you use is not controlled by a light switch, and 
do not use an extension cord that has a switch. The Zepto™ Power Console must 
remain powered on at all times to work properly. 
2.5. Turn on power for the Zepto™ Power Console using the small switch located on the 
rear power entry module where the power cord plugs in.  The Zepto™ Power Console 
will perform a self-check.  A successful Zepto™ Power Console self-check will result 
in a flashing green Status light. 
2.6. Open the package, and pass the Fluid Isolator to the operating attendant. 
2.7. Aseptically remove the Mynosys disposable Zepto™ Handpiece from the outer pouch 
and aseptically transfer the inner pouch to the scrub nurse.  
2.8. Remove the Fluid Isolator from the pouch. 
2.9. After retrieving the Zepto™ Handpiece from the inner pouch in a sterile manner, 
connect the disposable Zepto™ Handpiece suction line to the Fluid Isolator. 
2.10. Connect the 10cc syringe to the Fluid Isolator. 
2.11. Connect the Fluid Isolator to the Luer-Lok connector at the front of the Zepto™ Power 
Console. 
2.12. Connect the electrical cable to the 5 pin receptacle at the front panel of the Zepto™ 
Power Console. 
2.13. After the Zepto™ Handpiece self-check is successfully completed, the flashing green 
light will convert to a constant ON green light, indicating the system is ready.   
2.14. Pull the protective tip cover off the end of the disposable Zepto™ Handpiece, being 
careful not to damage the Zepto™ tip. 
 

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3. Surgical Procedure 
3.1. Create a clear corneal incision of 2.2mm or greater. 
3.2. Use an Ophthalmic Viscosurgical Device to stabilize the anterior chamber. 
3.3. Submerge ZeptoTM capsulotomy tip into sterile Balanced Salt Solution (BSS).   
3.4. Pull the syringe plunger to the end of travel.   
3.5. Slide the finger slider distally on the disposable Zepto™ Handpiece to elongate the 
Zepto™ capsulotomy tip for insertion into the corneal incision (Do not pull back on the 
finger slider until the Zepto™ capsulotomy tip has been inserted completely into the 
anterior chamber). 
3.6. Stabilize the eye with a Thornton fixation ring, and insert the Zepto™ capsulotomy tip 
through the corneal incision. 
3.7. Once the Zepto™ capsulotomy tip is fully within the anterior chamber, slide the finger 
slider proximally to return the capsulotomy tip to a circular state. 
3.8. Position the Zepto™ capsulotomy tip on the capsular bag, centering the device using 
the desired centration method.  
3.9. Instruct assistant to press the “Suction” button on the console to initiate suction cup and 
nitinol ring apposition onto the lens capsule. 
3.10. Visually confirm the flow of OVD has stopped by monitoring the movement of bubbles 
in the OVD.  When the OVD ceases to flow, full suction has been achieved.  
3.11. Instruct assistant to press the “Cut/Release” button on the console to perform the 
capsulotomy (once capsulotomy energy is delivered, the suction is automatically vented 
to atmosphere). 
3.12. Instruct assistant to introduce small amount of pre-loaded BSS into the suction cup to 
gently release the suction cup from the capsule (this is done by the assistant moving a 
roller clamp on the suction tubing). 
3.13. Stabilizing the eye with the Thornton fixation ring, remove the Zepto™ Handpiece 
capsulotomy tip from the anterior chamber by manually withdrawing it through the 
corneal incision.  The ZeptoTM capsulotomy tip automatically folds and conforms to the 
incision as it is withdrawn from the eye. 
3.14. The excised capsule “button” (circular piece of capsule tissue that has been cut) from 
the capsulotomy will be free-floating within the anterior chamber and can be retrieved 
by forceps. 
3.15. In the event of an incomplete capsulotomy with remaining tissue bridges, use the 
manual Continuous Curvilinear Capsulorhexis technique to complete the capsulotomy. 
 
F. 
POSTOPERATIVE CARE 
 
The subject will be instructed by the operating physician on normal post-op cataract surgery 
instructions. 
 
 

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G. 
DATA REPORTING 
 
 
A Case Report Form (CRF) binder will be used for each subject enrolled in the study. The 
appropriate CRF, provided under separate cover in a binder specific to this study, will be completed 
and signed by the investigator after each examination. All CRFs will be completed in a legible 
manner in ink. Any corrections will be made by drawing a single line through the incorrect entry, 
entering the correct information, and initialing and dating the change. 
 
 
H. 
STUDY COMPLETION PROCEDURES 
 
Subject Completion: Subjects are considered to have completed the study if they have completed all 
follow-up examinations through month 1.  
 
Subject Termination: Subjects may be terminated from the study at the discretion of the Principle 
Investigator only for reasons related to the study regimen that would jeopardize the subjects’ health 
and/or welfare if they were to continue in the study.  However, every effort will be made to follow 
terminated subjects for safety reasons using the appropriate case report forms until the planned end 
of the study period. 
 
Subjects Discontinuation/ Lost to Follow-up: Subjects may be discontinued from the study for non-
study-related reasons only when no other option is possible. Reasons for discontinuation include, but 
are not necessarily limited to:  
 
1) Voluntary withdrawal from the study by the subject;  
2) Subject has moved from the area and is determined to be lost to follow-up;  
3) Subject is unwilling or unable to cooperate with study requirements (follow-up visits, etc.).  
  
The reason for discontinuation will be recorded on the appropriate CRF. Only subjects discontinued 
prior to ZeptoTM capsulotomy may be replaced in the study.  Prior to discontinuing a subject, every 
effort should be made to contact the subject to either encourage the subject to maintain compliance 
with the protocol or to obtain as much follow-up data as possible regarding the subject’s current 
visual status. 
 
 
X. 
COMPLICATION AND ADVERSE EVENT REPORTING 
 
Safety reporting, as part of clinical research, can be different from what normally happens in clinical 
practice. A clinical investigator has a dual role, as a physician and as an investigator. These 
responsibilities are not in conflict but can lead to confusion while collecting, evaluating and reporting 
adverse events. As an investigator participating in research, it is important to understand the 
definition of an adverse event from a regulatory perspective. As listed below, the regulatory 
definition of an adverse event does not always equal the clinical definition and such events will need 
to be collected and documented, and in some cases reported in an expedited fashion.  
 
Regulations associated with clinical investigations generally define adverse events as undesirable 
occurrences or untoward medical occurrences. Most adverse events seen during a clinical 
investigation are not serious, as defined by the regulations. These non-serious adverse events are 

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collected and documented, but they do not need to be reported in an expedited fashion to the 
Sponsor, regulatory bodies, or the EC/IRB.  
 
A clinical investigator is obligated, as soon as they become aware of the event, to report to the 
Sponsor any adverse event determined to be serious as defined by the regulations or protocol. This is 
done for two reasons: first, to ensure the safety of all participants in the clinical investigation, and 
second, to meet reporting requirements of regulatory agencies.  
 
When a serious or non-serious adverse event occurs, the first concern will be the safety and welfare 
of the subject; treatment should be provided as appropriate for the event. During the study, the 
investigator should appropriately treat and follow-up each event until it resolves, stabilizes, or it is 
determined that further improvement is not expected.  
 
A. Definitions  
 
An Adverse Device Effect (ADE) is any untoward or unintended response to a medical device. This 
definition may include any event resulting from insufficiencies or inadequacies in the instructions for 
use or the deployment of the device or other device malfunctions. This definition includes any event 
that is a result of a user error.  
 
An Adverse Event (AE) is any untoward medical occurrence in a subject.  
 
A Device Failure/Device Malfunction is any occurrence where the medical device fails to operate 
in the intended manner or at all. Such a malfunction or failure may have no impact on subject 
treatment, may result in a subject related adverse event, or may prolong the total procedure time.  
 
Serious Adverse Device Effect (SADE) is any adverse device effect that results in any of the 
consequences characteristic of a serious adverse event or that may lead to any of these consequences 
if suitable action is not taken, or intervention is not made, or if circumstances are less opportune.  
 
Serious Adverse Events (SAEs) are adverse events that:  
•   Lead to death,  
•   Lead to serious deterioration in the health of the subject that:   
- Results in a life-threatening illness or injury,  
- Results in a permanent impairment of a body structure or function (i.e., blindness),  
- Requires in-patient hospitalization or prolongation of existing hospitalization,  
- Results in medical or surgical intervention to prevent permanent impairment to a body structure 
or a body function, or  
- Results in a potentially sight-threatening condition  
•  Lead to fetal distress, fetal death, a congenital abnormality, or birth defect.  
 
Unanticipated Adverse Device Event (UADE) is 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 or application (including a supplementary plan or application), or any other unanticipated 
serious problem associated with a device that relates to the rights, safety, or welfare of subjects.  
 
Unanticipated Adverse Event (UAE) is any adverse event, the nature, severity, or frequency of 

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which is not consistent with either:  
 
1. The known or foreseeable risk of adverse events associated with the procedures involved in the 
research that are described in (a) the protocol related documents, such as the IRB-approved 
research protocol, any applicable investigator brochure, and the current IRB-approved informed 
consent document, and (b) other relevant sources of information, such as product labeling and 
package inserts; or 
 
2. The expected natural progression of any underlying disease, disorder, or condition of the subject(s) 
experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse 
event.  
 
B. Identification and Collection  
 
Identification and collection of an adverse event begins after informed consent has been obtained and 
documented. Standard sources for identifying adverse events include:  
 
•  Direct observation by the investigator  
•  Asking the study participant a non-specific question (i.e., “Have you had any  
 
    
problems since the last visit?”)  
•  Unsolicited volunteering of information by the study participant (i.e., “Doctor, I have had 
numerous headaches since I started using this lens.”)  
•  Subject symptoms/complaints reported via subject questionnaire 
•  Laboratory or test results that meet protocol requirements for classification as an adverse 
event (e.g., IOP over 30 mmHg)  
 
The Investigator will review each event, assess its relationship to the ZeptoTM system and the severity 
of the event (see definitions provided below), will determine if the event is serious and if it is 
unanticipated. In addition, the Investigator will document subsequent treatment/intervention and 
resolution status for all Adverse Events. 
 
All adverse events and adverse device effects observed or elicited by the investigator, reported by the 
subject, or resulting from a test result, etc., occurring during the clinical investigation must be 
documented in the source documentation. All ocular adverse events are transcribed to the Adverse 
Event CRF. During the study, the investigator should treat the study subject as appropriate to ensure 
his/her safety and welfare.  
 
Cataract Surgery Adverse Events  
 
Specific to this protocol, pre-existing conditions (including cataract/planned cataract surgery on the 
non-study eye) will not be considered adverse event/serious adverse events, but will be collected at 
the preoperative visit. A worsening of a pre-existing condition during the study should be 
documented as an adverse event and evaluated accordingly.  
 
Although the following may be considered normal or expected events after cataract surgery, for 
purposes of this protocol, the following items must be documented as adverse events and evaluated 
accordingly:  
• Anterior capsule tear  

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• Posterior capsule rupture with or without vitreous loss  
• Choroidal effusion hemorrhage  
• Corneal edema, corneal decompensation  
• Corneal abrasion  
• Post-operative uveitis  
• Endophthalmitis  
• Posterior capsule opacification  
• Macular edema  
• Retinal tear or retinal detachment  
• Elevated intraocular pressure  
• Decentered IOL  
• Wound leak  
• Posterior vitreous detachment  
• Medication allergy or intolerance  
• Ptosis 
• Capsulotomy decentration 
• Zonular instability 
• Corneal burn 
• Corneal endothelial tear 
• Anterior capsule fibrosis/anterior capsule contraction syndrome  
 
 
C. Evaluation  
 
When evaluating adverse events, the investigator must determine if the event is serious, assess 
the severity of symptoms, the relationship of the event to the study device and study procedure, 
and whether or not the event was unanticipated using the following guidelines:  
 
1. Severity  
 
• Mild: Subject awareness of a sign or symptom that is easily tolerated, requires no treatment, 
and does not interfere with subject’s daily activities  
• Moderate: Subject awareness of a sign or symptom which may be a low level of concern to 
the subject and may interfere with daily activities, but can be relieved by simple therapeutic 
care  
• Severe: A sign or symptom that interrupts the subject’s daily activity and requires systemic 
therapy or other treatment. 
 
2. Relationship to Study Device or Study Procedures (Causality)  
 
• Probably: Any untoward medical occurrence reported in a subject, user, or other person, 
which might have a direct relationship to the study device/study protocol, including any 
malfunction, failure, deterioration in the characteristics or deployment and/or performance 
of the device, as well as any inadequacy in the labeling or the instructions for use, and an 
alternative cause is unlikely or significantly less likely compared to the potential 

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relationship to the study device/study protocol.  
• Possibly: Any untoward medical occurrence reported in a subject, user or other person, 
which might have a direct or indirect relationship to the study device/study protocol, 
including any malfunction, failure, deterioration in the characteristics or deployment and/or 
performance of the device, as well as any inadequacy in the labeling or the instructions for 
use and an alternative cause is equally or less likely compared to the potential relationship 
to the study device/study protocol.  
• Unlikely: Any untoward medical occurrence reported in a subject, user or other person, 
  which might have a little relationship to the study device/study protocol, including any 
malfunction, failure, deterioration in the characteristics or deployment and/or performance 
of the device, as well as any inadequacy in the labeling or the instructions for use and a 
likely alternative cause exists.  
• Unrelated: Any untoward medical occurrence reported in a subject, user or other person, 
which has no direct or indirect relationship to the study device/study protocol, and a more 
likely alternative cause (underlying or concurrent illness, effect of another 
procedure/device/drug) is identified or strongly suspected.  
 
D. Reporting  
 
1. On-Site Serious Adverse Event (SAE) Reporting  
 
The site should report any event to the Sponsor in an expedited manner if it meets the criteria 
for an SAE, or Serious Adverse Device Effect. Expedited reporting is calling, e-mailing, or 
faxing the Sponsor within 24 hours of becoming aware of the event. When calling or e-
mailing the Sponsor to report an SAE or Serious Adverse Device Effect, the site should 
forward any supporting documents along with the SAE Report Form to the Sponsor within 24 
hours of the initial call or e-mail and follow-up with CRF submission within 3 working days 
of identification. When faxing the notification and supporting documentation, the SAE Report 
should be included. Refer to the Personnel and Facilities section for Sponsor contact 
information for reporting of SAEs and Serious Adverse Device Effects. Sites must also report 
these events to the reviewing EC/IRB per their established reporting procedures.  
 
2. Off-Site Serious Adverse Event (SAE) Reports  
 
When participating in multi-center clinical trials, investigators may receive “off-site” reports 
(e.g., SAE Report). These are Sponsor reports of SAEs which occurred at other sites for the 
same trial, or in different trials using the same test article, that met the criteria for reporting to 
a regulatory agency. These will be reported to the applicable regulatory agency by the 
Sponsor. These should also be reported to the reviewing EC/IRB per their established 
reporting procedures.  
 
3. Unanticipated Adverse Events (UAEs)/Unanticipated Adverse Device Events (UADEs) 
Reports  
 
Unanticipated adverse events or unanticipated adverse device events must be reported either 
orally or in writing to the sponsor and the EC/IRB within 24 hours when it is known that the 

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event occurred.  
 
4. Device Failure/Device Malfunction Reports  
 
Where a device failure or device malfunction results in a serious or unanticipated adverse 
event/unanticipated adverse device event, the reporting requirements are those shown in (1) 
and (3) above. For cases where no serious adverse event or UAE/UADE occurs, the failure or 
malfunction should be reported to the Sponsor within 48 hours of the event being identified. 
 
 
E. Adverse Event Reporting Matrix  
 
The investigator will submit to the Sponsor representative a report of any SAE, SADE, ADE, 
UAE or UADE occurring during an investigation according to the following schedule.  In 
addition, device failure or malfunction which did not result in a UAE/UADE will also be reported 
according to the following schedule. 
 
Type of Report 
Submission Schedule 
Serious Adverse Event (SAE)/  
Serious Adverse Device Effect (SADE) 
verbal report within 24 hours followed by a written 
report within 3 working days  
Adverse Device Effect (ADE) 
verbal or written report within 10 working days 
Unanticipated Adverse Event (UAE) or 
Unanticipated Adverse Device Event (UADE) 
verbal report within 24 hours followed by a written 
report within 5 working days 
Patient Death 
verbal report within 24 hours followed by a written 
report within 5 working days 
Device Failure or Malfunction not resulting in 
UAE or UADE 
within 48 hours 
 
 
 F. Adverse Events (AEs) and Serious Adverse Events (SAEs) at Subject Exit  
 
If a subject is still being treated for an event at their last study visit, the ongoing event needs to 
be evaluated to determine appropriate follow-up for study purposes. Further follow-up may be 
needed as indicated below.  
 
1. Unrelated AEs and SAEs  
 
Ongoing AEs and SAEs classified as “Not Related” to study device and study procedures will 
be treated and followed until resolution or as dictated by standard of care. Documentation in 
the CRF of this follow-up is not required although subject care should continue as 
appropriate.  
 
2. Related AEs and SAEs  
 
Ongoing AEs classified as “Related” to the study device and study procedures will be treated 
and followed until resolution or as dictated by standard of care. Documentation in the CRF of 
this follow-up is not required although subject care should continue as appropriate.  
 

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Ongoing SAEs classified as “Related” to the study device and study procedures will be 
followed until their medical endpoints are determined or until no further change in the 
conditions are expected. 
 
 
 
 
XI. 
SAMPLE SIZE  
 
A. 
Primary Effectiveness Endpoint - Complete Capsulotomy (At least 95% of cases) 
 
The proposed sample size of 100 eyes, assuming a 95% success rate, will provide an 
exact 95% confidence interval of 88.72% to 98.36% around our point estimate.  
 
 
B.        Primary Safety Endpoint - Posterior Capsular Rupture & Vitreous Loss (4% or 
less) 
 
The proposed sample size of 100 eyes, assuming a posterior capsular tear and vitreous 
loss rate of 4%, will provide an exact 95% Confidence Interval of 1.10% to 9.93% around 
our point estimate. 
 
 
XII. 
DATA ANALYSIS 
 
Continuous data will be summarized with descriptive statistics (N, mean, standard deviation, 
minimum, median, and maximum).  Categorical variables will be summarized with N and 
percentage.  Binary endpoints, including both primary safety and primary effectiveness, will be 
summarized with proportion success and associated exact (Clopper-Pearson) 95% confidence 
interval.  All data summarized in tables will be presented in supportive line listings. 
 
The diameter of all ZeptoTM capsulotomies will be summarized as a continuous endpoint.  The 
proportion of ZeptoTM capsulotomies with anterior capsule tears or corneal touch will be reported 
along with its 95% exact confidence interval. The number and proportion of subjects 
experiencing specific adverse events will be tabulated by number and percentage of subjects 
experiencing those adverse events.  
 
Hypothesis testing will not be performed.  Point estimates and associated confidence intervals 
will be the basis of evaluation the effectiveness and safety of the device.  All analyses will be 
performed using SAS software version 9.4 
 
 
XIII. STUDY MONITORING 
 
Mynosys clinical study trained personnel and / or personnel from a Contract Research 
Organization will monitor all clinical studies in a manner consistent with any applicable health 
authority regulations and the clinical research standards adopted by the Mynosys clinical 

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department. Mynosys clinical study trained personnel and / or personnel from a Contract 
Research Organization will:  
 
1. Meet with investigator(s) prior to the initiation of the study to review the adequacy of the 
subject population, facilities, and equipment with respect to the needs of the study; to 
familiarize the investigator with the study protocol; and to reinforce GCP guidelines for 
clinical study conduct.  
 
2. Conduct interim monitoring visits and telephone consultation as necessary during the 
course of the study to ensure the proper progress and documentation of the study findings.  
 
3. Visit the clinical site when all subjects have completed the final visit of the study to collect 
the CRFs. 
 
 
  
 
  
 
 
 
  
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 

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XIV.  APPENDICES 
 
 
Appendix 1: Proposed Informed Consent Form 
 
 
 
RESEARCH SUBJECT INFORMATION AND CONSENT FORM 
 
 
TITLE: 
A PROSPECTIVE MULTI-CENTER STUDY OF ANTERIOR 
LENS CAPSULOTOMY USING THE MYNOSYS ZEPTOTM 
SYSTEM  
. 
 
 
PROTOCOL NO.: 
Sponsor    
 
MYN-002 
 
WIRB® Protocol # 
 
SPONSOR: 
Name  
 
Mynosys Cellular Devices, Inc. 
Address 
 
46710 Fremont Blvd 
 
City, State, Zip Code  Fremont CA 94538-6538 
 
Country 
 
 United States 
 
 
INVESTIGATOR: 
Name  
 
 
 
Address 
 
  
 
City, State, Zip Code   
 
Country 
 
   
 
STUDY-RELATED  
 
 
 
 
PHONE NUMBER(S): 
Name  
 
Dan Marinsik 
 
Phone Number(s)  
(510) 857-6296 
 
(24-hour number required for studies that are more than minimal 
risk)  
 
 
A person who takes part in a research study is called a research or study subject. In this consent 
form “you” always refers to the research subject. If you are a legally authorized representative, 
please remember that “you” means the research (study) subject. 
 
SUMMARY 
 
You are being asked to be in a research study. The purpose of this consent form is to help you 
decide if you want to be in the research study. 
 

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You should not join this research study until all of your questions are answered. 
 
Things to know before deciding to take part in a research study:   
 
• The main goal of a research study is to learn things to help patients in the future. 
 
• The main goal of regular medical care is to help each patient. 
 
• The decision to join or not join the research study will not cause you to lose any medical 
benefits. If you decide not to take part in this study, your doctor will perform the cataract 
surgery using standard techniques. 
 
• Parts of this study involve experimental (investigational) capsulotomy procedures that are 
being tested for a new device. An investigational device is one that has not been approved 
by the U.S. Food & Drug Administration (FDA). 
 
• After reading the consent form and having a discussion with the research staff, you 
should know which parts of the study are experimental and which are standard medical 
care. 
 
• Your medical records may become part of the research record. If that happens, your 
medical records may be looked at and/or copied by the sponsor of this study and 
government agencies or other groups associated with the study. 
 
• Your medical insurance WILL be billed for any standard medical care you receive during 
the research study. You will be responsible for the costs of your standard medical care. 
You will not be charged for the study portion of your care. Your insurance company will 
not be billed for the research portion of your care. If your insurance company is billed 
then it may have access to the research records. Insurance companies may not pay for 
treatment that is part of a research study.  
 
 
PURPOSE OF THE STUDY 
 
The purpose of this study is to determine whether the Mynosys ZeptoTM System is safe and 
effective in performing anterior capsulotomies during cataract surgery.   
 
PROCEDURES 
 
You will have eye surgery to have cataracts removed and as part of the surgery, a capsulotomy 
will be performed using the Mynosys Zepto™ System. A capsulotomy is a surgical procedure in 
which a circular incision is made into the capsule of the crystalline lens of the eye. This 
procedure will take less than 1 minute.  After that, the device will be removed from your eye. 
After completion of the capsulotomy, the physician performs the rest of the cataract surgery 
procedure following his standard routine for this surgery. 
 

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After the surgery, you will be prescribed with antibiotic eye drops to prevent infection and anti-
inflammatory eye drops to help reduce any internal inflammation. You'll need to apply the eye 
drops several times daily for about the first week during your recovery from cataract surgery.   
This medication is not part of the study, but is standard treatment for cataract surgery.   
 
All qualified subjects in the study will have a capsulotomy created by the Mynosys Zepto™ 
system. If both your eyes require cataract surgery, only one eye will have a capsulotomy with the 
Zepto™ system.   The other eye will receive a capsulotomy using your physician’s standard 
technique.  The eye receiving the Zepto™ capsulotomy will be chosen randomly. 
 
RISKS AND DISCOMFORTS  
 
• What are the possible risks or discomforts?  
• Risks of Eye Examination and Dilation: 
• As part of the eye exam, drops will be put in your eyes to dilate the pupils.  This is a 
standard procedure during cataract surgery and not specific to the study.  The drops may 
blur your vision and make you sensitive to light for several hours.  There is a small risk 
of an allergic reaction to the drops.  There is also a small risk that the drops could cause 
the eye pressure to raise.  If this happens, it will be treated, but there is a very small risk 
of losing vision from the pressure rise.  Due to the blurring effect of your vision and 
possible light sensitivity, you will be advised not to drive until the drops have worn off 
and, if necessary, to have someone come with you who can drive after the exam. 
 
• Other Risks from Cataract Surgery: 
• You should be aware that there may be additional risks or side effects that are currently 
unknown and unforeseeable, such as capsular tears, corneal edema, corneal abrasion, 
infection or bleeding inside of the eye, and blurred vision. 
 
Women who are pregnant may not take part in this study. Women that have not been confirmed 
to be post-menopausal or surgically sterilized will be given a Serum β-HCG test prior to your 
cataract surgery to confirm that you are not pregnant.   
 
Other Risks 
Your condition may not get better or may get worse during this study.  
 
BENEFITS 
 
It is possible that the Mynosys Zepto™ System could improve your outcome after cataract 
surgery. However, this is an initial study so there is no clinical evidence to support this at this 
time. 
 
COSTS 
 
You will be charged for standard medical care. You will not be charged extra for the study 
portion of your care. Tests and procedures that are done only for the study will not be billed to 
you or your insurance company.  

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PAYMENT FOR PARTICIPATION   
 
You will receive limited payment for travel expenses for being in this study.  You will be 
reimbursed $25 for each study visit after the initial screening visit.  Reimbursement is to defray 
travel costs. 
 
Transportation assistance will be provided (if needed for subsequent visits) in the form of up to 
$50 taxi fare reimbursement, or arrangement for other transportation.  Please ask the study staff 
if you need transportation assistance. 
 
ALTERNATIVE TREATMENT  
If you choose not to participate in this study, your doctor will discuss alternative surgical 
techniques to perform the capsulotomy required for your cataract surgery.   
 
You do not have to take part in this study to receive treatment for your condition.  One of the 
surgical alternatives available to people with cataracts requiring a capsulotomy is a technique 
called a Continuous Curvilinear Capsulorhexis (CCC).  The treatment may also be done using a 
femtosecond laser.  You may also choose to receive no treatment at all.   
 
AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH 
PURPOSES  
 
What information may be used and given to others? 
The study doctor will get your personal and medical information. For example:  
 
• Past and present medical records 
• Research records 
• Records about phone calls made as part of this research 
• Records about your study visits 
 
Who might get this information? 
The sponsor of this research. “Sponsor” means any persons or companies that are: 
 
• Working for or with the sponsor, or  
• Owned by the sponsor. 
 
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
 
May I review or copy my information? 
Yes, but only after the research is over.  
 
May I withdraw or revoke (cancel) my permission? 
You may withdraw or take away your permission to use and disclose your health information at 
any time. You do this by sending written notice to the study doctor. If you withdraw your 
permission, you will not be able to stay in this study. 

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When you withdraw your permission, no new health information identifying you will be 
gathered after that date. Information that has already been gathered may still be used and given to 
others.  
 
Confidentiality  
Information from this study will be given to the sponsor. “Sponsor” includes any persons or 
companies that are contracted by the sponsor to have access to the research information during and 
after the study. 
 
The information will also be given to the U.S. Food and Drug Administration (FDA). It may be 
given to governmental agencies in other countries where the Zepto™ System may be considered for 
approval. Medical records which identify you and the consent form signed by you will be looked at 
and/or copied for research or regulatory purposes by: 
 
• the sponsor, 
• Promedica, an agent for the sponsor, 
• Kevin Waltz, O.D., M.D., the medical monitor for this study, 
 
And may be looked at and/or copied for research or regulatory purposes by: 
 
• the FDA, 
• Department of Health and Human Services (DHHS) agencies, 
• California State Food and Drug Branch 
• governmental agencies in other countries, and 
• Western Institutional Review Board® (WIRB®). 
 
Absolute confidentiality cannot be guaranteed because of the need to give information to these 
parties. The results of this research study may be presented at meetings or in publications. Your 
identity will not be disclosed in those presentations. 
 
COMPENSATION FOR INJURY 
If you are injured or get sick as a result of study procedures, call the study doctor immediately. 
The study doctor will provide emergency medical treatment.  
 
 
VOLUNTARY PARTICIPATION AND WITHDRAWAL 
Your participation in this study is voluntary. You may decide not to participate or you may leave 
the study at any time. Your decision will not result in any penalty or loss of benefits to which 
you are entitled. 
 
Your participation in this study may be stopped at any time by the study doctor or the sponsor 
without your consent for any reason, including: 
 
• if it is in your best interest 
• if you do not consent to continue in the study after being told of changes in the research that 
may affect you 

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If you leave the study before the planned final visit, you may be asked by the study doctor to 
have some tests or procedures done so that you leave the study safely. 
 
QUESTIONS 
If you have questions about your rights as a research subject or if you have questions, concerns or 
complaints about the research, you may contact: 
 
 
Western Institutional Review Board® (WIRB®) 
 
1019 39th Avenue SE Suite 120 
 
Puyallup, Washington 98374-2115 
 
Telephone:  1-800-562-4789 or 360-252-2500 
 
E-mail:  Help@wirb.com 
 
WIRB is a group of people who independently review research. 
 
WIRB will not be able to answer some study-specific questions, such as questions about 
appointment times. However, you may contact WIRB if the research staff cannot be reached or if 
you wish to talk to someone other than the research staff.  
 
Do not sign this consent form unless you have had a chance to ask questions and have gotten 
satisfactory answers. 
	  
If you agree to be in this study, you will receive a signed and dated copy of this consent form for 
your records. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
 
 
 

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CONSENT 
 
I have read this consent form (or it has been read to me). All my questions about the study and 
my part in it have been answered. I freely consent to be in this research study. 
 
I authorize the release of my medical and research records for the purpose of this study. 
By signing this consent form, I have not given up any of my legal rights. 
 
 
 
__________________________________________ 
Subject Name (printed) 
 
 
 
__________________________________________ 
__________________ 
Signature of Subject 
Date 
 
 
 
__________________________________________ 
__________________ 
Printed Name of Person Conducting the 
Position 
Informed Consent Discussion 
 
 
 
________________________________________ 
__________________ 
Signature of Person Conducting the  
Date 
Informed Consent Discussion 
 
ASSENT SIGNATURES, For Subjects with a Legally Authorized Representative: 
Assent: 
For subjects who have a legally authorized representative, I confirm that: 
• I have explained the study to the extent compatible with the subject’s understanding, and 
the subject has agreed to be in the study. 
OR  
• The subject is not able to assent due to lack of mental capacity. 
 
 
 
__________________________________________ 
__________________ 
Signature of Person Conducting Assent Discussion 
Date 
 

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ASSENT SECTION: 
Statement of person conducting assent discussion: 
 
• I have explained all aspects of the research to the subject to the best of his or her ability 
to understand. 
• I have answered all the questions of the subject relating to this research. 
•  The subject agrees to be in the research. 
• I believe the subject’s decision to enroll is voluntary. 
• The study doctor and study staff agrees to respect the subject’s physical or emotional 
dissent at any time during this research when that dissent pertains to anything being done 
solely for the purpose of this research.  
 
Ver. 07/06/2016 
 
 

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Appendix 2: Schedule of Visits and Clinical Parameters 
 
 
 
Screening 
   Day 0 
   Day 1 
  Week 1 
 Month 1 
Informed Consent 
X 
 
 
 
 
Ophthalmic History 
X 
 
 
 
 
Inclusion/Exclusion 
X 
 
 
 
 
Dilated Pupil Size 
X 
 
 
 
 
Intraocular Pressure 
X 
 
 
 
 
Manifest Refraction 
X 
 
 
 
 
Uncorrected distance visual acuity 
(UCVA) 
X 
 
 
 
 
Best spectacle corrected distance visual 
acuity (BSCVA) 
X 
 
 
 
 
Slit Lamp 
X 
 
 
 
 
Fundus Examination 
X 
 
 
 
 
 ZeptoTM Capsulotomy 
 
X 
 
 
 
Completeness of Capsulotomy 
 
X 
 
 
 
Observation of Corneal Touch 
 
X 
 
 
 
Observation of Posterior Capsule 
Rupture 
 
X 
 
 
 
Observation of Anterior Capsule Tear 
 
X 
 
 
 
Capsulotomy Diameter 
 
X 
 
 
 
Adverse Events 
 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 

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Appendix 3: Methods of Clinical Evaluation 
 
 
A. 
Dilated Pupil Size  
 
 
 
Pupil size will be measured preoperatively by the slit lamp beam. 
                        The slit lamp beam will be adjusted vertically using the micrometer scale. 
                        The vertical size of the pupil will be recorded, understanding that the  
                        measured pupil size by this technique will be approximately 1.15x of the 
                        actual pupil size. 
 
B. 
Measurement of Intraocular Pressure 
 
Intraocular pressure should be measured using Goldmann or Pascal 
applanation tonometry or other validated methods.   
 
C. 
Completeness of Capsulotomy 
 
  
 
By surgeon observation during surgery 
 
 
D. 
Observed Corneal Touch 
 
 
 
 
By surgeon observation during surgery 
 
 
E. 
Observed Posterior Rupture 
 
 
 
 
By surgeon observation during surgery 
 
F. 
Observed Anterior Tear 
 
 
 
By surgeon observation during surgery 
 
G. 
Capsulotomy Size 
 
 
 
The diameter of the ZeptoTM capsulotomy will be measured by the 
surgeon using a rhexis ruler (MST Seibel Capsulorhexis Forceps with Rhexis 
Ruler™ and ViewPort, dull tips (Cat. DFH-0029).  The rhexis ruler is inserted 
into the anterior chamber after ZeptoTM capsulotomy.  The rhexis ruler is placed 
gently on top of the capsulotomy opening and the capsulotomy diameter is read 
off the markings on the rhexis ruler.  The capsulotomy diameter is recorded and 
the rhexis ruler is removed from the anterior chamber. 
 
 
 

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Appendix 4: Sponsor’s Commitments 
 
 
 
Mynosys Cellular Devices is committed to: 
 
1. 
Complying with the Declaration of Helsinki and all applicable health authority 
regulations governing the conduct of clinical trials. 
 
2. 
Protecting the rights, health, safety, and welfare of study subjects. 
 
3. 
Informing the clinical Investigators of any new information about the study which 
may affect the health, safety or welfare of the subjects, or may influence their 
decision to continue participation in the study. 
 
4. 
Providing the clinical Investigators with the study protocol, and a full set of Case 
Report Forms (CRFs) to document the study report writing resources necessary to 
complete reporting of the study results. 
 
5. 
Providing the statistical analysis and study report writing resources necessary to 
complete reporting of the study results. 
 
6. 
Ensuring equity of consideration among all Investigators in multi-center studies in 
all matters of publications, meeting presentations, etc. 

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Appendix 5: Investigator’s Qualifications and Responsibilities 
 
Each investigator must be a licensed physician who has completed a residency or preceptorship in 
ophthalmology.  The investigators have the following responsibilities 
 
1. 
Subject Selection:  The investigator is responsible for assuring that all subjects entering the 
study conform to the subject selection criteria. 
 
2. 
Informed Consent:  The Investigator is responsible for fully reviewing the nature of the study, 
the possible risks, and alternative treatments with prospective subjects prior to their enrollment in the 
study. The investigator is responsible for obtaining written Informed Consent in compliance with 21 
CFR 50 for each subject, prior to enrollment in the trial. A copy of the signed Informed Consent Form 
will be maintained in the subject’s medical record and a copy will be given to the subject. 
 
3. 
Subject Evaluations and Data Reporting: The Investigator is responsible for performing the 
subject evaluations as described in the study protocol. All information generated by the subject 
evaluation will be recorded on the Subject Case Report Forms (CRFs) provided by the Sponsor. The 
CRFs will be filled out in black ink or will be typewritten. Any corrections will be made by lining out 
the incorrect information, entering the correct information, and initialing and dating the change. 
Correction fluid will not be used. The Investigator will sign and date each individual form upon its 
completion and will return the originals, not copies, to the Sponsor. Copies of all CRFs will be retained 
in the Investigator’s office in order to be available for monitoring by Mynosys personnel. 
 
Immediately upon completion of each subject examination the completed, signed, and dated CRF shall 
be submitted to the Sponsor for review and statistical analysis.  Investigators will not deviate from the 
study protocol without prior approval of Mynosys unless protection of the health, safety or welfare of 
study subjects requires prompt action. 
 
4. 
Institutional Review Board (IRB) Approval: The Investigator must obtain approval for his 
participation in this protocol from the IRB for the institution at which the procedure will be performed, 
prior to entering any subjects in the study. The Informed Consent document to be used will also be 
submitted by the Investigator to the IRB for approval prior to initiation of the study.  
 
5. 
Conduct of the Study: The Investigator will conduct the study in accordance with Good 
Clinical Practice as set forth by the FDA. 
 
6. 
Record Retention: The Investigator shall maintain all subject records for whichever of the 
following periods is shortest: 
a. A period of five years after the date on which the FDA approves the marketing of the device 
for the purpose that was the subject of the study. 
 
b. A period of five years after the date on which the results of the study are submitted to the FDA 
in support of the marketing of the device for the purpose that was the subject of the study.  
 
 
 
 

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Appendix 6: Investigator Agreement 
 
Clinical Study Agreement 
 
This Clinical Study Agreement (“Agreement”) is by and between Mynosys Cellular Devices 
Inc., a Delaware corporation, located at 46710 Fremont Blvd Fremont CA 94538 (“SPONSOR”) 
and (Insert Physician’s Name), located at (Insert Physician’s Address) (“ORGANIZATION”).  
 
SPONSOR is performing a clinical investigation under the Study Protocol “A PROSPECTIVE 
MULTI-CENTER STUDY OF ANTERIOR LENS CAPSULOTOMY USING THE MYNOSYS 
ZEPTOTM SYSTEM” (“Protocol”), attached hereto as Exhibit A. 
 
1. 
Study Services 
ORGANIZATION will provide the following operative study services under the “Protocol:” 
• Routine procedure-related disposables and consumables required for a successful 
outcome. 
 
2. 
Privacy Laws 
SPONSOR agrees that it’s use and disclosure of patient health and medical information is subject 
to compliance with applicable state and federal privacy laws.  SPONSOR, therefore, agrees to 
take all reasonable steps to protect the confidentiality of any patient health and medical 
information that it has access to and comply with applicable state and federal privacy laws, 
including the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 
(HIPAA).  The obligations set forth in this Section shall survive the termination of this 
Agreement. 
 
3. Indemnification 
SPONSOR agrees to indemnify, defend and hold harmless ORGANIZATION, its trustees, 
officers, agents and employees against any claims, suits or judgments made or instituted against 
ORGANIZATION to the extent that they are caused by the defect or malfunction of the 
investigational device or product used in STUDY, except to the extent that such claim or 
judgment is based upon negligence or willful malfeasance by ORGANIZATION.  
ORGANIZATION agrees to notify SPONSOR as soon as it becomes aware of any such claim or 
action and to cooperate with and authorize SPONSOR to carry out the sole management and 
defense of any such claim or action.  SPONSOR agrees, at its own expense, to provide attorneys 
to defend against any actions brought or filed against ORGANIZATION, its trustees, officers, 
agents, employees with respect to the indemnity contained herein, whether or not such claims or 
actions are rightfully brought or filed. 
ORGANIZATION agrees to indemnify, defend and hold harmless SPONSOR, its trustees, 
officers, agents and employees against any claims, suits or judgments made or instituted against 
SPONSOR arising out of or connected with any activities of ORGANIZATION that result from 
the negligence or willful malfeasance of ORGANIZATION or any of its authorized agents, 

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except to the extent that such claims, suits or judgments are based upon negligence or willful 
malfeasance by SPONSOR. 
 
4. Insurance 
SPONSOR shall maintain the following minimum levels of insurance or self-insurance: $1 
million per occurrence and $3 million aggregate (i) Worker’s Compensation and Employers 
Liability insurance, (ii) Commercial General Liability insurance, and (iii) Errors and Omissions 
insurance. 
 
ORGANIZATION shall maintain the following minimum levels of insurance or self-
insurance:$1 million per occurrence and $3 million aggregate (i) Worker’s Compensation and 
Employers Liability insurance, (ii) Commercial General Liability insurance, and (iii) Errors and 
Omissions insurance. 
 
5. Independent Contractors 
The relationship between ORGANIZATION and SPONSOR is that of independent contractors.  
The ORGANIZATION is not in a relationship of joint venture, partnership or employer-
employee with SPONSOR.  None of the provisions of the Agreement shall be construed to create 
nor are they intended to create a relationship of partnership, agency, joint venture or employment 
between ORGANIZATION and SPONSOR. 
 
6. Jurisdiction 
This Agreement shall be interpreted and governed by the laws of the State of California.  
 
7. Term and Termination 
This Agreement shall be effective upon the execution of this Agreement by both parties, and will 
end upon completion of the study in accordance with approved protocol.  Either party may 
terminate this Agreement upon thirty (30) days written notice.   
 
8. Notices 
Any notice given pursuant to this Agreement will be written and sent to: 
 
 
 
 
 
(Insert Physician’s Name, Practice and address) 
 
 
 
 
The individuals signing this Agreement are authorized to do so and all necessary approvals and 
authorizations have been made prior to the signing of this Agreement. 

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Mynosys Cellular Devices, Inc. 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 
 
 
 
Name 
 
 
 
 
 
 
 
 
(Date) 
 
 
 
Physician’s Practice 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name  
 
 
 
 
 
 
 
 
 
 
 
 
______ 
(Date) 
 
 
 
 
 
 

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Appendix 7: Declaration of Helsinki 
 
 
BASIC PRINCIPLES 
 
1. Biomedical research involving human subjects must conform to generally accepted scientific 
principles and should be based on adequately performed laboratory and animal 
experimentation and on a thorough knowledge of the scientific literature. 
2. The design and performance of each experimental procedure involving human subjects should 
be clearly formulated in an experimental protocol, which should be transmitted to a specially 
appointed independent committee for consideration, comment and guidance. 
3. Biomedical research involving human subjects should be conducted only by scientifically 
qualified persons and under the supervision of a clinically competent medical person.  The 
responsibility for the human subject must always rest with a medically qualified person and 
never rest on the subject of the research, even though the subject has given his or her consent. 
4. Biomedical research involving human subjects cannot legitimately be carried out unless the 
importance of the objective is in proportion to the inherent risk to the subject. 
5. Every biomedical research project involving human subjects should be preceded by careful 
assessment of predictable risks in comparison with foreseeable benefits to the subject or to 
others.  Concern for the interests of the subject must always prevail over the interests of 
science and society. 
6. The right of the research subject to safeguard his or her integrity must always be respected.  
Every precaution should be taken to respect the privacy of the subject and to minimize the 
impact of the study on the subject’s physical and mental integrity and on the personality of the 
subject. 
7. Doctors should abstain from engaging in research projects involving human subjects unless 
they are satisfied that the hazards involved are believed to be predictable.  Doctors should 
cease any investigation if the hazards are found to outweigh the potential benefits. 
8. In publications of the results of his or her research, the doctor is obliged to preserve the 
accuracy of the results.  Reports of experimentation not in accordance with the principles laid 
down in this Declaration should not be accepted for publication. 
9. In any research on human beings, each potential subject must be adequately informed of the 
aims, methods, anticipated benefits and potential hazards of the study and the discomfort it 
may entail.  He or she should be informed that he or she is at liberty to abstain from 
participation in the study and that he or she is free to withdraw his or her consent to 
participation at any time.  The doctor should then obtain the subject’s freely given informed 
consent, preferably in writing. 
10. When obtaining informed consent for a research project the doctor should be particularly 
cautious if the subject is in a dependent relationship to him or her or may consent under duress.  
In that case the informed consent should be obtained by a doctor who is not engaged in the 
investigation and who is completely independent of this official relationship. 
11. In case of legal incompetence, informed consent should be obtained from the legal guardian in 
accordance with national legislation.  Where physical or mental incapacity makes it impossible 
to obtain informed consent, or when the subject is a minor, permission from the responsible 
relative replaces that of the subject in accordance with national legislation. 

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12. The research protocol should always contain a statement of the ethical considerations involved 
and should indicate that the principles enunciated in the present Declaration are complied with. 
 
 
II. MEDICAL RESEARCH COMBINED WITH PROFESSIONAL CARE                     
(CLINICAL RESEARCH) 
1. In the treatment of the sick person, the doctor must be free to use a new diagnostic and 
therapeutic measure, if in his or her judgment it offers hope of saving life, reestablishing 
health, or alleviating suffering. 
2. The potential benefits, hazards and discomfort of a new method should be weighed against 
the advantages of the best current diagnostic and therapeutic methods. 
3. In any medical study, every subject – including those of a control group, if any – should be 
assured of the best-proven diagnostic and therapeutic methods. 
4. The refusal of the subject to participate in a study must never interfere with the doctor-
subject relationship. 
5. If the doctor considers it essential not to obtain informed consent, the specific reasons for this 
proposal should be stated in the experimental protocol for transmission to the independent 
committee (I.1). 
6. The doctor can combine medical research with professional care, the objective being the 
acquisition of new medical knowledge, only to the extent that medical research is justified by 
its potential diagnostic or therapeutic value for the patient. 
 
 
III. NON-THERAPEUTIC BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS 
(NON-CLINICAL BIOMEDICAL RESEARCH) 
1. In the purely scientific application of medical research carried out on a human being, it is the 
duty of the physician to remain the protector of the life and health of that person on whom 
biomedical research is being carried out. 
2. The subjects should be volunteers – either healthy persons or patients for whom the 
experimental design is not related to the patient’s illnesses. 
3. The investigator or the investigating team should discontinue the research if in his/her or their 
judgment it may, if continued, be harmful to the individual. 
4. In research on man, the interest of science and society should never take precedence over 
considerations related to the well-being of the subject. 
 
 
 

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Appendix 8: References 
 
1. 
Chang, D.F., Mamalis, N. & Werner, L. Precision Pulse Capsulotomy: Preclinical Safety 
and Performance of a New Capsulotomy Technology. Ophthalmology 123, 255-264 
(2016). 
2. 
Simanovskii, D., et al. Cellular Tolerance To Pulsed Heating. SPIE Proceedings, Laser-
Tissue Interactions XVI 5695(2005). 
3. 
Carifi, G., et al. Complications and outcomes of phacoemulsification cataract surgery 
complicated by anterior capsule tear. Am J Ophthalmol 159, 463-469 (2015). 
4. 
Agrawal, V., Upadhyay, J. & Indian Cataract Risk Stratification Study, g. Validation of 
scoring system for preoperative stratification of intra-operative risks of complications 
during cataract surgery: Indian multi-centric study. Indian J Ophthalmol 57, 213-215 
(2009). 
5. 
Androudi, S., et al. Posterior capsule rupture and vitreous loss during 
phacoemulsification with or without the use of an anterior chamber maintainer. J 
Cataract Refract Surg 30, 449-452 (2004). 
6. 
Ang, G.S. & Whyte, I.F. Effect and outcomes of posterior capsule rupture in a district 
general hospital setting. J Cataract Refract Surg 32, 623-627 (2006). 
7. 
Chan, F.M., et al. Short-term outcomes in eyes with posterior capsule rupture during 
cataract surgery. J Cataract Refract Surg 29, 537-541 (2003). 
8. 
Desai, P., Minassian, D.C. & Reidy, A. National cataract surgery survey 1997-8: a report 
of the results of the clinical outcomes. Br J Ophthalmol 83, 1336-1340 (1999). 
9. 
Greenberg, P.B., et al. Prevalence and predictors of ocular complications associated with 
cataract surgery in United States veterans. Ophthalmology 118, 507-514 (2011). 
10. 
Hyams, M., et al. Intraoperative complications of phacoemulsification in eyes with and 
without pseudoexfoliation. J Cataract Refract Surg 31, 1002-1005 (2005). 
11. 
Ionides, A., Minassian, D. & Tuft, S. Visual outcome following posterior capsule rupture 
during cataract surgery. Br J Ophthalmol 85, 222-224 (2001). 
12. 
Lundstrom, M., Barry, P., Leite, E., Seward, H. & Stenevi, U. 1998 European Cataract 
Outcome Study: report from the European Cataract Outcome Study Group. J Cataract 
Refract Surg 27, 1176-1184 (2001). 
13. 
Martin, K.R. & Burton, R.L. The phacoemulsification learning curve: per-operative 
complications in the first 3000 cases of an experienced surgeon. Eye (Lond) 14 ( Pt 2), 
190-195 (2000). 
14. 
Mearza, A.A., Ramanathan, S., Bidgood, P. & Horgan, S. Visual outcome in cataract 
surgery complicated by vitreous loss in a district general hospital. Int Ophthalmol 29, 
157-160 (2009). 
15. 
Tan, J.H. & Karwatowski, W.S. Phacoemulsification cataract surgery and unplanned 
anterior vitrectomy--is it bad news? Eye (Lond) 16, 117-120 (2002). 
16. 
Zaidi, F.H., Corbett, M.C., Burton, B.J. & Bloom, P.A. Raising the benchmark for the 
21st century--the 1000 cataract operations audit and survey: outcomes, consultant-
supervised training and sourcing NHS choice. Br J Ophthalmol 91, 731-736 (2007).