Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)

K233325 · Visionary Optics, LLC · HQD · Feb 21, 2024 · Ophthalmic

Device Facts

• Record ID: K233325
• Device Name: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
• Applicant: Visionary Optics, LLC
• Product Code: HQD · Ophthalmic
• Decision Date: Feb 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzman's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring from infection or trauma. The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, astigmatism or presbyopia. Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Story

Large-diameter rigid gas permeable (RGP) contact lens; vaults over cornea; rests on scleral conjunctiva. Lathe-cut from fluoro-silicone acrylate materials (roflufocon D/E, hexafocon A/B, tisilfocon A, fluoroxyfocon A). Prescribed by eye care practitioners for daily wear; manages irregular corneal shapes and ocular surface diseases; provides expanded tear reservoir and environmental protection. May incidentally correct refractive errors. Shipped wet or dry in specialized cases; requires chemical cleaning/disinfection. Benefits include improved vision and ocular surface stability for patients with complex corneal conditions.

Clinical Evidence

Retrospective clinical evaluation of 33 patients (63 eyes) managed with fluoroxyfocon A scleral lenses. Patients monitored for at least 3 months (median 113 days). Primary endpoints: ocular adverse reactions and stability of ocular condition/vision. Results: No serious or significant adverse reactions reported; all patients showed stable or improved ocular conditions and vision.

Technological Characteristics

Rigid gas permeable contact lens; materials: roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A (FDA Group #3 fluoro-silicone acrylate). Lathe-cut manufacturing. Diameter 12.00-26.00mm; water content <1%. UV-blocking. Complies with ANSI Z80.20 tolerances.

Indications for Use

Indicated for patients with irregular corneal shape (keratoconus, keratoglobus, pellucid marginal degeneration, Salzman's nodular degeneration), corneal dystrophies, post-surgical corneal conditions (transplant, LASIK, radial keratotomy), corneal scarring, ocular surface disease (dry eye, Sjogren's, GVHD), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure. May also correct refractive error (myopia, astigmatism, presbyopia) in these patients.

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

• Visionary Optics Scleral Contact Lens (K223394)
• Acuity 200 (Fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K203571)

Submission Summary (Full Text)

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February 21, 2024

Visionary Optics LLC % Bret Andre Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn. OR 97068

Re: K233325

Trade/Device Name: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: September 25, 2023 Received: January 23, 2024

Dear Bret Andre:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# J Angelo Green -S

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## 510(k) Number (if known) K233325

### Device Name

Visionary Optics Scleral Contact Lens (roflufocon E. hexafocon A. hexafocon B. tisilfocon A. fluoroxyfocon A)

## Indications for Use (Describe)

The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzman's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring from infection or trauma.

The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, astigmatism or presbyopia.

Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510 (k) SUMMARY

This special 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | K233325 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| I. SUBMITTER | |
| Date Prepared: | September 25, 2023 |
| Name:<br>Address | Visionary Optics LLC<br>1325 Progress Drive<br>Front Royal, VA 22630 |
| Contact Person: | Donald R. Sanders<br>Manager and CEO |
| Phone number: | [phone] |
| Consultant/<br>Correspondent: | Andre Vision and Device Research<br>Bret Andre<br>6119 Canter Lane<br>West Linn, OR 97068 |
| Phone number | [phone] |
| II. DEVICE | |
| Trade Name: | Visionary Optics Scleral Contact Lens<br>(roflufocon D, roflufocon E, hexafocon A,<br>hexafocon B, tisilfocon A, fluoroxyfocon A) |
| Common<br>Name: | Daily wear rigid gas permeable contact lens |
| Classification<br>Name:<br>886.5916) | Rigid gas permeable contact lens. (21 CFR) |
| Regulatory<br>Class: | Class II |
| Product Code: | HQD |

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#### III. PREDICATE DEVICE

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) is substantially equivalent to the following predicate devices:

- · Visionary Optics Scleral Contact Lens (roflufocon E, hexafocon A, hexafocon A, hexafocon B, tisilfocon A) Manufactured by Visionary Optics LLC 510(k) number; K223394
- · Acuity 200 (Fluoroxyfocon A) Rigid Gas Permeable Contact Lens Manufactured by Acuity Polymers, Inc. 510(k) number: K203571

#### IV. DEVICE DESCRIPTION

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Visionary Optics Scleral Contact Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, or fluoroxyfocon A.

| | ROFLUFOCON D | ROFLUFOCON E | HEXAFOCON<br>A | HEXAFOCON<br>B | TISILFOCON<br>A | FLUOROXYFOCON<br>A |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Refractive Index | 1.4333 | 1.4332 | 1.415 | 1.4240 | 1.4378 | 1.430 |
| Light Transmission<br>(clear) | >97% | >97% | - | >95% | - | - |
| Light Transmission<br>(tinted) | >90% | >90% | >92% | >83% | >91% | >87% |
| Water Content | <1% | <1% | <1% | <1% | <1% | <1% |
| Oxygen<br>Permeability<br>(Dk)<br>ISO/FATT Method | $100 \times 10^{-11}$ (cm²/sec)<br>(ml O₂/ml x mm Hg @<br>35°C) | $125 \times 10^{-11}$ (cm²/sec)<br>(ml O₂/ml x mm Hg @<br>35°C) | $140 \times 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $141 \times 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $180 \times 10^{-11}$<br>(cm²/sec) (ml O₂/ml<br>x mm Hg @ 35°C) | $200 \times 10^{-11}$ (cm²/sec)<br>(ml O₂/ml x mm Hg @ 35°C) |
| Contain one or<br>more of the<br>following color<br>additives<br>conforming to:<br>21 CFR Part 73 &<br>74, Subpart D | D & C Green No.<br>6, FD & C Red<br>No. 17,<br>CI Solvent Yellow<br>18 | D & C Green No.<br>6, FD & C Red<br>No. 17,<br>CI Solvent<br>Yellow 18 | D&C Green<br>No. 6; D&C<br>Yellow No. 18;<br>D&C Violet<br>No. 2; | D&C Green<br>No. 6; C.I.<br>Solvent Yellow<br>No. 18; D&C<br>Violet No. 2;<br>D&C Red No.<br>17 | D&C Green<br>No. 6, C.I.<br>Solvent<br>Yellow No.<br>18, D&C<br>Violet No. 2<br>and D&C Red<br>No. 17 | D&C Green No. 6;<br>D&C Violet No. 2;<br>Solvent Yellow 18:<br>D&C Red No. 17 |
| UV Light Blocking | Yes | Yes | Yes | Yes | Yes | Yes |

The physical properties of the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) are as follows:

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The available parameters for the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) are as follows:

| Parameter | Range | Tolerance |
|-------------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Base Curve | 5.5mm to 25.00mm | $\pm$ 0.2mm |
| Center Thickness | 0.10mm to 3.00mm | $\pm$ 0.1mm |
| Diameter | 12.00mm to 26.00mm | $\pm$ 0.20mm |
| Spherical Power | -35.00 D to +35.00 D<br>(in .12D steps) | $\pm$ 0.12 (0 to = 5D)<br $\pm$ 0.18 (5 to = 10.0D)<br $\pm$ 0.25 (10 to = 15D)<br $\pm$ 0.37 (15 to = 20D)<br $\pm$ 0.50 (over 20D) |
| Cylindrical Power | +10.00 D to -10.00 D<br>(in .12 D steps) | $\pm$ 0.25 (0 to = 2D)<br $\pm$ 0.37 (2 to = 4D)<br $\pm$ 0.50 (over 4D) |
| Cylindrical Axis | 1° to 180° (in 1º steps) | $\pm$ 5° |
| Bifocal Add | +.12 D to +6.00 D<br>(in .12 D steps) | $\pm$ 0.25D |

The Visionary Optics Scleral Contact Lens may be shipped "dry" or "wet". The primary container for shipping the Visionary Optics Scleral Contact Lens is the PolyVial Contact Lens Case. When shipped "wet", the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) are packaged and shipped in Boston Simplus Multiaction Solution. When shipped "wet", the Visionary Optics Scleral Contact Lens (tisilfocon A) is packaged and shipped in Menicon Unique pH Solution.

#### V. INDICATIONS FOR USE

The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring from infection or trauma.

The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graftversus-Host disease, Sjogren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders, disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic. paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the Visionarv Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, hyperopia, astigmatism or presbyopia.

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Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care svstem.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) is substantially equivalent to the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon B, tisilfocon A) (predicate device - K223394) in the following areas:

- Components/Materials/Formulation (roflufocon D, roflufocon E, hexafocon A, hexafocon B, and tisilfocon A contact lens materials)
- Manufacturing facility, procedures and controls ●
- Product code (HQD) ●
- . Classification (Class II) - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
- FDA material group - group # 3 fluoro silicone acrylate
- . Lathe cut manufacturing process
- Scleral (large diameter) design ●
- Actions and intended use ●
- . Therapeutic (Irregular Cornea, Ocular Surface Disease) indications for use

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) is substantially equivalent to the Acuity 200 (Fluoroxyfocon A) Rigid Gas Permeable Contact Lens (predicate device - K203571) in the following areas:

- Components/Materials/Formulation (fluoroxyfocon A contact lens material) ●
- Product code (HQD) ●
- Classification (Class II) Lenses, Rigid Gas Permeable, Daily Wear (21 CFR . 886.5916)
- FDA material group - group # 3 fluoro silicone acrylate
- Lathe cut manufacturing process
- Scleral (large diameter) design ●
- Actions and intended use .
- Therapeutic (Irregular Cornea) indications for use ●

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The following table depicts the classification and technical characteristics of the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) in comparison with the predicate devices.

| | Visionary Optics Scleral<br>Contact Lens | Visionary Optics Scleral<br>Contact Lens | Acuity 200 (Fluoroxyfocon A)<br>Rigid Gas Permeable Contact<br>Lens |
|----------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------|
| | Subject Device | Predicate Device | Predicate Device |
| 510(k) Number | | K223394 | K203571 |
| Intended Use | Daily Wear | Daily Wear | Daily Wear |
| Device and<br>Classification | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily Wear<br>HQD | Class II<br>Lenses, Rigid Gas Permeable,<br>Daily Wear<br>HQD | Class II<br>Lenses, Rigid Gas Permeable,<br>Daily Wear<br>HQD |
| Product Code | HQD | HQD | HQD |
| Production Method | Lathe-cut | Lathe-cut | Lathe-cut |
| Material (USAN) | Roflufocon D<br>Roflufocon E<br>Hexafocon A<br>Hexafocon B<br>Tisilfocon A<br>Fluoroxyfocon A | Roflufocon D<br>Roflufocon E<br>Hexafocon A<br>Hexafocon B<br>Tisilfocon A | Fluoroxyfocon A |
| FDA Group # | Group # 3 Fluoro Silicone<br>Acrylate | Group # 3 Fluoro Silicone<br>Acrylate | Group # 3 Fluoro Silicone<br>Acrylate |
| Water Content | <1% | <1% | <1% |
| UV Absorber/Blocker<br>available | YES | YES | YES |

| | Indications for Use |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Visionary<br>Optics Scleral<br>Contact Lens<br>(Subject<br>Device) | The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management of<br>multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus,<br>keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan'<br>dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant,<br>LASIK, radial keratotomy), and corneal scarring from infection or trauma. |
| | The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of<br>ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren's<br>syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and<br>thermal burns, radiation, filamentary keratitis), epidermal ocular disorders, disorders of the skin (e.g. atopy,<br>ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia),<br>and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear<br>reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted<br>cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide<br>correction of refractive error in persons with myopia, hyperopia, astigmatism or presbyopia.<br>Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens<br>may be cleaned and disinfected using a chemical (not heat) lens care system. |

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| Visionary<br>Optics Scleral<br>Contact Lens<br>(Predicate<br>Device:<br>K223394) | The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management of<br>multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus,<br>keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's<br>dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant,<br>LASIK, radial keratotomy), and corneal scarring from infection or trauma.<br>The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of<br>ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren's<br>syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and<br>thermal burns, radiation, filamentary keratitis), epidermal ocular disorders, disorders of the skin (e.g. atopy,<br>ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia),<br>and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear<br>reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted<br>cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide<br>correction of refractive error in persons with myopia, hyperopia, astigmatism or presbyopia.<br>Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens<br>may be cleaned and disinfected using a chemical (not heat) lens care system. |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acuity 200<br>(Fluoroxyfocon<br>A) Rigid Gas<br>Permeable<br>Contact Lens<br>(Predicate<br>Device:<br>K203571) | The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the<br>correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic<br>persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes<br>that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus,<br>pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.<br>The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected<br>using a chemical (not heat) lens care system. |

#### VII. PERFORMANCE DATA

## ~ Non-Clinical Studies ~

Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A has been addressed by reference to previous 510(k) clearances.

# Additionally, the following testing was performed on finished Visionary Optics Scleral Contact Lenses (fluoroxyfocon A):

Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Visionary Optics LLC to manufacture lenses, on a repeatable basis, from fluoroxyfocon A supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.

Bioburden Testing-bioburden testing conducted on fluoroxyfocon A rigid gas permeable lenses manufactured at Visionary Optics LLC demonstrated that the colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens.

{10}------------------------------------------------

## ~ Clinical Studies ~

Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, hexafocon B and tisilfocon A with the labeled indications for use has been addressed through previous 510(k) clearances.

Nine (9) independent practitioners evaluated 33 patients (63 total eyes) presenting with various conditions that were managed using scleral contact lenses manufactured by Visionary Optics from Acuity 200 (fluoroxyfocon A) material. The practitioners reviewed all patients therapeutically managed for ocular surface disease with Visionary Optics Scleral Contact Lens (fluoroxyfocon A) for at least 3 months, and reported the outcome of each patient-including any ocular adverse reactions or worsening of the patients' conditions-over the treatment period. All patients were fit with successful outcomes over a treatment follow-up period of at least 3 months (Min: 90 days; Max: 259 days; Median: 113 days). The total number of days of treatment follow-up for all patients combined was There were no serious or significant adverse reactions reported. For all 4.306 days. patients, the ocular condition(s) and vision remained stable or improved during management with the Visionary Optics Scleral Contact Lens (fluoroxyfocon A).

~ Conclusions Drawn from Testing ~

Results from testing presented in this premarket notification for the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) demonstrate no relevant differences from the predicate devices and supports the substantial equivalence claim.

## VIII. CONCLUSIONS

## Substantial Equivalence

Information presented in this premarket notification establishes that Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) for daily wear are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indications.

## Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of rigid gas permeable (RGP) daily wear contact lenses. The benefits to the patient are the same as those for other RGP contact lenses.