SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS

K052675 · Synergeyes · HQD · Nov 30, 2005 · Ophthalmic

Device Facts

• Record ID: K052675
• Device Name: SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS
• Applicant: Synergeyes
• Product Code: HQD · Ophthalmic
• Decision Date: Nov 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irreqular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

Device Story

Hybrid contact lens featuring rigid gas permeable (RGP) center (paflufocon D) and soft hydrophilic skirt (hem-iberfilcon A). Lens acts as refracting medium to focus light on retina. Designed for patients with keratoconus and irregular astigmatism. Lathe-cut manufacturing; e-beam sterilized. Used in clinical settings; prescribed and fitted by eye care professionals. Output is visual correction; patient benefits from improved visual acuity compared to traditional lenses. Clinical decision-making based on patient refractive error and corneal topography. Lens requires chemical disinfection compatible with both RGP and hydrogel materials.

Clinical Evidence

Prospective, multi-site, open-label study (n=62). Primary endpoints: safety (adverse events, visual acuity loss) and effectiveness (visual acuity). 71% completion rate. Final VA 20/40 or better in 83.9% of completed eyes. Average daily wear time 11.4 hours. Adverse events included mechanical abrasion, transient IOP changes, and infiltrates. Study concluded lens provides satisfactory performance for keratoconus correction.

Technological Characteristics

Hybrid lens: RGP center (paflufocon D, Dk 145 FATT) and soft skirt (hem-iberfilcon A, 27% water). Diameter 14.5mm. Base curves 5.50-7.70mm. Power range -20.00 to +20.00D. E-beam sterilization. Non-ionic surface charge. Visibility blue tint.

Indications for Use

Indicated for daily wear correction of hyperopia, myopia, and irregular astigmatism (up to 6.00 D) in aphakic and non-aphakic, non-diseased eyes. Power range: -20.00 to +20.00 D.

Regulatory Classification

Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

Predicate Devices

• SynergEyes™ A and M (paflufocon D hem-iberfilcon A) (K051035)
• SoftPerm (synergicon A) Mixed use Lens (K051035, P840004/S7)
• Paragon Vision Sciences (P870024/S36, P870024/S43, K940277)

Submission Summary (Full Text)

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NOV 3 0 2005

SynergEyes™, Inc. Carlsbad, CA 92008

Applicant's Name and Address

SynergEyes™, Inc. 1926 Kelloga Ave. Suite 100 Carlsbad, CA 92008 [phone]

Contact Person

Richard Lippman, OD FAAO Vice President Ophthalmic Regulatory Products R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road Suite 30 Rockville, Maryland 20850 [phone]

#### 1. Identification of device

Common Name: Trade Name:

Classification:

Contact Lens SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Lens for Keratoconus Daily Wear Soft (hydrophobic) Contact Lens Class II (21 CFR 886.5916)

#### 2. Description of device

Device classification:

The SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens is a The Oyliogeyes - RO (pananoos contact lens corneal optic portion surrounded by a soft hydrophilic skirt that straddles the limbus of the eye :

- in the power range of -20.00 to +20.00 diopters for sphere, -0.50 to -6.00D cylinder .
- with center thickness from 0.18mm to 0.30mm .
- with base curves of 5.50mm to 7.70mm .
- with diameter of 14.50mm .

The lens material (paflufocon D hem-iberfilcon A) is identical to the predicate current material The teller (paners) There are no differences to the chemical composition, formulation, cleared "inder" (100 room "herilization as described in the referenced 510(k).

This lens material for the rigid portion is paflufocon D lathe cut, surrounded by soft hydrophilic This lens material for the nga portion by means of e-beam sterilization. When placed on the Copolymer (fichlinen Fr), ecentiable »), nect Lens acts as a refracting medium to focus light rays onto the retina. The device is available as a lathe cut contact lens in the following design for rays onto the rolline. The visibility tinted material. This device is equivalent to Keraloconus: In A and M Hybrid Contact Lens is material design and composition, and the the SyneigEyes - A and M Hykeratoconus and manufactured by Ciba Vision Corporation.

The SynergEyes™ KC Hybrid Daily Wear Contact Lens is a rigid gas permeable material of The soft skirt is comprised of HEMA (paflulofon-D) rigid gas permeable polymer. (hydroxyethylmethacrylate of 27% water and 73% polymer.

The junction between the rigid material is bound by a proprietary chemical bonding method.

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SynergEyes™, Inc. Carlsbad, CA 92008

#### 3. Intended use

SynergEves™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irreqular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

#### 4. Predicate devices

The predicate lens SynergEyes™ A and M (paflufocon D hem iberfilcon A) was selected to address: material (silicone acrylate- paflufocon D) for the optic portion of the lens and (hemiberfilcon A) for the soft skirt portion of the lens. Additionally for lens design (hybrid RGP/soft), lens group (silicone acrylate RGP and Group I low water non-ionic for the soft material. Further equivalence to predicate devices for indication for use and parameter comparison.

Predicate Devices:

- For the Hybrid (RGP-soft skirt concept) .

| SynergEyes™, Inc.<br>SoftPerm (synergicon A) Mixed use Lens | K051035<br>P840004/S7 | Cleared: Sep. 2, 2005<br>App: 10/14/1993 |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------|
| • For the RGP Center Portion: | | |
| Paragon Vision Sciences | P870024/S36 and S43<br>App: 11/23/1993 and 4/13/2002<br>K940277<br>Cleared: 5/9/1994 | |
| • For the Soft Skirt Portion: | | |
| SynergEyes™, Inc.<br>SoftPerm (synergicon A) Mixed use lens | K051035<br>P840004/S7 | Cleared: 9/2/2005<br>App: 10/14/1993 |

#### 5. Characteristics

The physical and dimensional characteristics of the SynergEyes™ Hybrid Contact Lens are compared to the characteristics of the predicate device SoftPerm® Contact Lens in the following table.

| Lens Characteristics | SynergEyes TM K<br>(paflufocon D-<br>iberfilcon A)<br>Hybrid Contact<br>Lens<br>(Subject Device) | SynergEyesTM A<br>and M (paflufocon<br>D- iberfilcon A)<br>Hybrid Contact<br>Lens<br>K051035<br>(Predicate Device) | SoftPerm®<br>(synergicon A)<br>Contact Lens<br>P840004/S7<br>(Predicate Lens) |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Manufacturer | SynergEyesTM Inc. | SynergEyesTM Inc. | Ciba Vision Care |
| Base Curves | 5.50-7.70mm | 7.10-9.00mm | 7.10-8.10mm |
| RGP Center | 8.40mm | 8.40mm | 8.00mm |
| Posterior Optic Zone | 9.0mm | 7.80mm | 7.00mm |

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| Diameter | | | |
|-----------------------------|-------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------|
| Lens Designs | Sphere, Aspheric,<br>Front Surface<br>Toric, | Sphere, Aspheric,<br>Front Surface<br>Toric, Multifocal | Sphere, Front<br>Surface Toric |
| Diameters: | 14.5mm | 14.5mm | 14.3mm |
| Power Range | -20.00 to + 20.00D | -20.00 to + 20.00D | -13.00 to +6.00D |
| Cylinder Power Range | 0.50 to 6.00D | 0.50 to 10.00D | |
| Center Thickness | 0.18 to 0.30mm | 0.12 to 0.30mm | 0.08mm to<br>0.28mm |
| Refractive Index (RGP) | 1.442 (Nd @ 25°C) | 1.442 (Nd @ 25°C) | 1.53 |
| Wetting Angle (RGP) | 42° | 42° | 21° CLMA |
| Specific Gravity (RGP) | 1.10 | 1.10 | 1.015 |
| Hardness | 79 | 79 | |
| Indications for Use | Daily Wear | Daily Wear | Daily Wear |
| UV Blocking | No | No | No |
| Material | Paflufocon D center<br>RGP hem-iberfilcon<br>A (HEMA, MEMA) | Paflufocon D center<br>RGP hem-iberfilcon<br>A (HEMA, MEMA) | Synergicon A<br>RGP and HEMA<br>Skirt |
| Tint | Visibility Blue | Visibility Blue | Clear |
| Soft Skirt Water<br>Content | 27% | 27% | 25% |
| Core (RGP) Water<br>Content | < 1% | < 1% | < 0.2% |

#### 6. Non clinical studies:

Results from the series of physical/chemical and toxicological tests were conducted under K051035 for the equivalent lens, the predicate lens for this device. All tests may be referenced to K051035 of the sponsor, SynergEyes, Inc.

Non-clinical studies included in K051035 and summarized here are:

- Chemistry and leachability: Residual monomer testing was conducted in accordance . with Standardized protocols adopted by US and ISO standards. The results indicated that the residuals were of trace levels, and not toxic to test animals.
- Toxicology (cytotoxicity, Ocular Irritation, and Systemic Injection)- Testing was . conducted on extracts of the hybrid lens material for all three biocompatibility tests and found to be non-toxic for each of the test protocols run on these materials.
- Solution Compatibility-Compatibility was demonstrated by subjecting10 lenses to a 30 . cycle disinfection regimen with approved solutions. Results indicated that the subject lenses were compatible with lens solutions that are approved for both soft and RGP material.
- Microbiology/Sterilization: The finished lenses were subject to e-beam sterilization and . found to be sterilized using standard USP protocol. Initial shelf life was established at one year. Extensions of shelf-life are subject to the same protocol which incorporates acceleration aging backed by real-time studies, and all subject to end time sterility verification.

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#### 7. Packaging

The primary lens container for shipping is a sterile enclosed medical grade glass vial capped with a screw cap and sterilized with the e-beam sterilization process. The lens is immersed in a sterile buffered normal saline.

#### 8. Clinical data:

A one month clinical study of the SynergEyes™ KC Hybrid Contact Lens was conducted to assess safety and effectiveness for vision correction in daily wear that included subjects with keratoconus and irregular astigmatism with refractive errors including myopia, hyperopia, and/or astigmatism. The purpose of the study was to profile the outcome endpoints and patient acceptance of the SynergEyes™ KC Hybrid Contact Lens for the conditions described herein. The primary outcomes for safety was adverse events and loss of visual acuity. The primary outcome for effectiveness was contact lens visual acuity by eye. Additional effectiveness outcomes included percentage of completed subjects and lens wearing time. The primary safety endpoints included visual acuity loss of greater than 2 lines of vision, assessment of serious adverse events, complications, and symptoms, problems, and complaints among others.

The study was designed as a prospective, multi-site, open label study with a 1 month aggregate lens wearing period for each completing subject. Subjects were enrolled at 12 sites and must have satisfied the patient inclusion and exclusion criteria specified in the protocol. Prior lens experience was recorded. Data were collected at baseline, dispensing and follow-up visits of 1 and 2 weeks, and 1 month.as well as unscheduled visits.

The population demographics were similar to previous contact lens studies with a female to male gender ratio of 1.48 to 1.0. The average age of the completed and discontinued subjects was 40.7 and 39.4 respectfully.

There were a total of 62 subjects who were dispensed and evaluated of which 44 (71%) subjects completed, and 18 (29%) subjects were discontinued.

| Figure 1 | | |
|----------------------------|-----------------|-------|
| Reason For Discontinuation | Over All Visits | |
| | # Subjects | % |
| Poor Comfort | 7 | 38.9% |
| Poor Outcome with Lenses | 3 | 16.7% |
| Other | 3 | 16.7% |
| Poor Vision | 2 | 11.1% |
| Non-Compliance | 2 | 11.1% |
| Loss of Interest | 1 | 5.6% |
| Total Subjects | 18 | |

The distribution of the reasons for discontinuation is enumerated below.

The "Other" reasons for discontinuation included: "moving to Japan", "moved 4 hours away", and "Iens ripping - too time consuming to restart".

The most frequent reasons cited for subject discontinuation were Poor Comfort (15 subjects, 32.6%) and Loss of Interest (13 subjects, 28.3%). Thirteen (13) of the 15 subjects discontinued for Poor Comfort exited the study within the first month of lens wear. One lens complication reported as 'Poor outcome with lenses' in one patient (2 eyes) with corneal abrasions was treated and resolved.

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#### Safety Assessment:

Four (4) adverse events were reported during the study for 2 completed subjects and 2 discontinued subjects. . One subject presented with mechanical abrasion on the apex of the cone in both eyes after several lens dispensing visits, one subject experienced transient changes in intraocular pressures in both eyes at the 1 week follow-up visit, one subject presented with edema and infiltrates in the left eye 61 days after first lens dispensing, and one subject presented with a red left eye with small infiltrates 14 days after first lens dispensing.

The safety analysis was enhanced by slit lamp (biomicroscopic) examinations which were performed at each follow-up visit to evaluate the ocular surface to determine if there was evidence that the study lenses initiated or aggravated changes to the corneal surface. The results of the examinations show characteristics of subjects with keratoconus with relatively high rates of staining, injection, edema and neovascularization.

Staining was reported for 50.1% completed eyes, 52.0% for discontinued eyes of which 4.0% and 3.3% was reported respectfully for moderate (Gr. 3) staining. Injection was reported for 44.7% completed eyes and 42.3% for discontinued eyes of which 0.7% and 0.8% was reported respectfully for moderate (Gr. 3) injection. Neovascularization was reported for 22.6% completed eyes, and 14.6% discontinued eyes of which only 1 severe neovascularization (Gr. 4) was reported for a discontinued eye. The subject entered the study with the same degree of neovascularization. Finally, edema was reported for 4.0% completed eyes, and 15.4% for discontinued eyes of which no reports of moderate (Gr. 3) or severe (Gr. 4) findings were received.

The most common symptoms, problems, and complaints for completed eyes were cited as discomfort/awareness (26.0%), dryness/scratchiness (12.5%), blurred vision (11.7%), and itching/burning (10.6%). These rates were higher for discontinued patients (41.6%, 18.7%, 24.7%, and 13.9% respectfully.

#### Efficacy Assessment:

Visual Acuity- Final visual acuity for completed subjects was 20/20 or better (26.3%), 20/25 or better (55.1%), 20/30 (71.4%), and 20/40 or better (83.9%). The visual acuity rates for discontinued subjects were 8.4%, 27.8%, 47.2%, and 52.8% respectfully. Vision correction fluctuated as expected with the instability of the corneal curvature from keratoconus under the contact lens contributing to the change. Five (5) completed eyes and 3 discontinued eyes were reported to have VA decreases of more than 2 lines of Snellen VA when comparing the contact lens VA with the best corrected VA. These findings are expected with this population.

For Wearing Time: Over the study period the average daily wearing time reported by completed patients was 11.4 hours per day.

#### Conclusion:

The SynergEyes™ KC Hybrid Contact Lens for Keratoconus provided satisfactory performance as expected. The higher than estimated discontinuation rate was anticipated due to the nature of the subject population with the inclusion of subjects who might otherwise have less successful outcomes with other lens types. Overall, the lens performance demonstrated safe and effective use of the device for its intended use.

#### 9. Conclusions drawn from studies Substantial Equivalence:

Information provided in this 510(k) establishes that the SynergEyes™Hybrid Contact Lens are miomator in optical, chemical and physical properties of the predicate devices and do not raise

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SynergEyes™, Inc. Carlsbad, CA 92008

any questions of safety and effectiveness. The clinical evaluation demonstrated safe and effective lens performance, and where possible equivalence to historical experience with predicate devices. The device is substantially equivalent to the predicate devices material, SynergEyes A and M Hybrid Contact Lens (K051035), Paragon HDS-100 (P870024/S36 and S43), and (K940277); and SoftPerm (synergicon A) contact lens (P840004/S7), and indication for use as a hybrid lens material comprised of a rigid center optic portion and a soft skirt portion.

| | SynergEyes™ KC<br>Hybrid Contact Lens<br>for Keratoconus | Jurkus<br>(1998) | Chung<br>(2001) |
|----------------------|----------------------------------------------------------|----------------------|------------------------------------------------------|
| No. of Lenses (Eyes) | 116 | 21 | 35 |
| No. Patients | 62 | 11 | 28 |
| Gender | 40F/27M | 5F/6M | 11F/17M |
| Mean Age | 40.7 (Completed) | | 41 + 19 |
| Lens | SynergEyes KC | Saturn II (SoftPerm) | SoftPerm/Prior RGP<br>users |
| Indication | Myopia, Hyperopia,<br>Irr. Astimgatism | Astigmatism | Keratoconus 22/35<br>(62.9%) and PK 10/35<br>(28.8%) |
| Completions | 44 (71%) | 4 (36%) | 17 (66.7%) |
| Discontinuations | 18 (29%) | 7 (64%) | 11 (33.3%) |
| For Comfort | 38.9% | 28% | 45.5% |
| For Vision | 11.1% | 28% | 9.1% |

## Clinical Experience Equivalence to Other Studies

#### Material Equivalence Table

| | SynergEyes™ K Hybrid Contact Lens for Keratoconus | SynergEyes™ A and M Hybrid Contact Lens for Daily Wear | SoftPerm® Contact Lens |
|-------------------------------------|---------------------------------------------------------|---------------------------------------------------------|-------------------------------------------|
| PRODUCTION METHOD | Subject Device<br>Lathing | (K051035)<br>Lathing | P840004/S7<br>Lathing |
| INTENDED USE | Daily Wear | Daily Wear | Daily Wear |
| MATERIAL | Paflufocon D Center<br>hem-iberfilcon A skirt | Paflufocon D Center<br>hem-iberfilcon A skirt | Synergicon-A |
| Type | Group 1 Low Water | Group 1 Low Water | Group 1 Low Water |
| Surface Charge | Non-ionic | Non-ionic | Non-ionic |
| Color additive<br>(Scientific name) | D&C Green 6 | D&C Green 6 | |
| UV additive | No | No | No |
| Dk permeability: | RGP Center:<br>FATT: 145<br>ISO: 100<br>Soft Skirt: 9.3 | RGP Center:<br>FATT: 145<br>ISO: 100<br>Soft Skirt: 9.3 | RGP Center:<br>ISO: 14<br>Soft Skirt: 5.5 |

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SynergEyes™, Inc. Carlsbad, CA 92008

| Dk/L- Lens<br>transmissibility:<br>1. Revised FATT<br>(Through power range -20<br>to + 20D) | FATT: | 66-77 | FATT: | 66-77 | | |
|---------------------------------------------------------------------------------------------|-------|-------|-------|-------|--------|------|
| | ISO: | 46-53 | ISO: | 46-53 | ISO: | 17.5 |
| 2. ISO 9913-1 Polarimetric<br>method : | | | | | | |
| Light transmittance<br>(380nm to 780nm) | >90% | | >90% | | 88-92% | |

#### Risk and Benefits:

The risks of the subject device are the same as those normally attributed to the wearing of RGP and soft (hydrophilic) contact lenses on a daily wear base. The benefits to the patient are the same as those for other RGP and soft (hydrophilic) contact lenses. Overall, the risks and benefits associated with daily wear contact lenses are the same as for other daily wear contact lenses and raise no additional concerns for safety or effectiveness.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. Above the caduceus, the text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern. Below the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern.

# NOV 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SynergEyes, Inc. C/O Richard E. Lippman, O.D., F.A.A.O. Vice President for Ophthalmic Product Regulatory Affairs P. Chiacchierini & Associates, LLC 15825 Shady Grove Rd., Suite 30 Rockville, MD 20850

K052675 Re:

Trade/Device Name: SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lens for Keratoconus for Daily Wear Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD Dated: September 23, 2005 Received: September 27, 2005

Dear Dr. Lippman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class HI (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Richard E. Lippman, O.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| SYNERGEYES, INC. | SECTION 3 |
|------------------------------------------------------------------------------------------|------------------------------|
| 510(k) Premarket Notification | INDICATION FOR USE STATEMENT |
| SYNERGEYES™ (paflufocon<br>D hem-iberfilcon A) HYBRID<br>CONTACT LENS FOR<br>KERATOCONUS | DAILY WEAR CONTACT LENS |

# SECTION 2 : INDICATIONS FOR USE STATEMENT

510(k) Number (if known) _K 052675

Device Name: SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lens for Keratoconus

### Indication for Use

SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and –20.00 D in eyes with irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:left;">✓</div> |
|------------------|---------------------------------------|
|------------------|---------------------------------------|

OR Over-the-counter-use ______

| (Division Sign-off) | River Warbutor |
|--------------------------------|----------------|
| Division of Ophthalmic Devices | |
| 510(k) Number | K052675 |