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

K223394 · Visionary Optics, LLC · HQD · Dec 7, 2022 · Ophthalmic

Device Facts

• Record ID: K223394
• Device Name: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)
• Applicant: Visionary Optics, LLC
• Product Code: HQD · Ophthalmic
• Decision Date: Dec 7, 2022
• Decision: SESE
• Submission Type: Special
• 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, 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 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 conjunctiva overlying sclera. Lathe-cut from fluorosilicone acrylate materials (roflufocon D, roflufocon E, hexafocon B, or tisilfocon A). Prescribed by eye care practitioners for daily wear; frequent/planned replacement. Provides expanded tear reservoir; protects ocular surface from adverse environments; corrects refractive errors. Shipped dry or wet in compatible lens care solutions. Patient benefits include improved vision for irregular corneas and therapeutic protection for ocular surface diseases.

Clinical Evidence

No new clinical data provided. Safety and effectiveness established via reference to previous 510(k) clearances for the specified materials and indications. Bench testing performed to verify manufacturing repeatability per ANSI Z80.20 and bioburden limits (<100 CFU/lens).

Technological Characteristics

Rigid gas permeable contact lens; materials: roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A (FDA Group #3 fluorosilicone acrylate). Lathe-cut manufacturing. Dimensions: 12.00-26.00mm diameter, 5.5-25.00mm base curve. Oxygen permeability (Dk) ranges 100-180 x 10^-11. UV blocking included. ANSI Z80.20 standards applied.

Indications for Use

Indicated for patients requiring management of irregular corneal shape (keratoconus, etc.), corneal dystrophies, post-surgical corneal conditions, corneal scarring, or therapeutic management of ocular surface disease (dry eye, limbal stem cell deficiency, neurotrophic keratitis, corneal exposure). May provide incidental refractive correction for myopia, astigmatism, or presbyopia.

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 (K171950)
• Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (K212631)

Submission Summary (Full Text)

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December 7, 2022

Visionary Optics LLC % Bret Andre Principal Consultant EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068

Re: K223394

Trade/Device Name: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: November 4, 2022 Received: November 8, 2022

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 (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 located 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.

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.

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

Also, please note the regulation titled, "Misbranding by reference to premarket notification" (21 CFR Part 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-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

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-regulatoryassistance/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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K223394

## Device Name

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon 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, 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 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 ( <i>Select one or both, as applicable</i> ) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="padding-right: 5px;"> <span style="font-size: 16px;"><b> </b></span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="padding-left: 20px; padding-right: 5px;"> <span style="font-size: 16px;"><b> </b></span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# SPECIAL 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: | K223394 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------|
| I. SUBMITTER | |
| Date Prepared: | November 4th, 2022 |
| Name:<br>Address | Visionary Optics LLC<br>1325 Progress Drive<br>Front Royal, VA 22630 |
| Contact Person:<br>Phone number: | Donald R. Sanders<br>Manager and CEO<br>[phone] |
| Consultant/<br>Correspondent: | EyeReg Consulting, Inc.<br>Bret Andre<br>6119 Canter Lane<br>West Linn, OR 97068 |
| Phone number | [phone] |
| II. DEVICE | |
| Trade Name: | Visionary Optics Scleral Contact Lens (roflufocon D,<br>roflufocon E, hexafocon A, hexafocon B, tisilfocon A) |
| Common<br>Name: | Daily wear rigid gas permeable contact lens |
| Classification<br>Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| 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) is substantially equivalent to the following predicate devices:

- "Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, . hexafocon B)" Manufactured by Visionary Optics LLC
510(k) number; K171950

- o "Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses" Manufactured by Contamac Ltd. 510(k) number; K212631
### DEVICE DESCRIPTION IV.

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon 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 fluorosilicone acrylate materials: roflufocon D, roflufocon E, hexafocon B, or tisilfocon A.

| | ROFLUFOCON D | ROFLUFOCON E | HEXAFOCON A | HEXAFOCON B | TISILFOCON A |
|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Refractive Index | 1.4333 | 1.4332 | 1.415 | 1.4240 | 1.4378 |
| Light Transmission<br>(clear) | >97% | >97% | | >95% | |
| Light Transmission<br>(tinted) | >90% | >90% | >92% | >83% | >91% |
| Water Content | <1% | <1% | <1% | <1% | <1% |
| Oxygen Permeability<br>(Dk)<br>ISO/FATT Method | $100 x 10^{-11}$ (cm²/sec)<br>(ml O₂/ml x mm Hg @ 35°C) | $125 x 10^{-11}$ (cm²/sec)<br>(ml O₂/ml x mm Hg @ 35°C) | $140 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $141 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $180 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) |
| Contain one or more<br>of the following color<br>additives conforming<br>to:<br>21 CFR Part 73 & 74,<br>Subpart D | D & C Green No. 6,<br>FD & C Red No. 17,<br>CI Solvent Yellow<br>18 | D & C Green No. 6,<br>FD & C Red No.<br>17,<br>CI Solvent Yellow<br>18 | D&C Green No.<br>6; D&C Yellow<br>No. 18; D&C<br>Violet No. 2; | D&C Green No.<br>6; C.I. Solvent<br>Yellow No. 18;<br>D&C Violet No.<br>2; D&C Red<br>No. 17; | D&C Green No.<br>6, C.I. Solvent<br>Yellow No. 18,<br>D&C Violet No.<br>2 and D&C Red<br>No. 17 |
| UV Light Blocking<br>(UVB - 280nm -<br>315nm; UVA 316nm -<br>380nm) | >98% UVB<br>>95% UVA | >98% UVB<br>>95% UVA | >95% UVB<br>>97% UVA | >95% UVB<br>>97% UVA | >98% UVB<br>>85% UVA |

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

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

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

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) 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 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), evidermal 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 Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, hyperopia, 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/planned

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replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. PREDICATE DEVICE

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) is substantially equivalent to the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) (predicate device - K171950) in the following areas:

- Components/Materials/Formulation (roflufocon D, roflufocon E, hexafocon A, and ● hexafocon B contact lens materials)
- Manufacturing facility, procedures and controls o
- 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 indications for use o

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) is substantially equivalent to the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (predicate device - K212631) in the following areas:

- Components/Materials/Formulation (tisilfocon A contact lens material) ●
- Product code (HOD) ●
- 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 indications for use o

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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) in comparison with the predicate devices.

| | Visionary Optics Scleral<br>Contact Lens | Visionary Optics Scleral<br>Contact Lens | Optimum Infinite<br>Daily Wear Contact Lenses |
|----------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|
| | Subject Device | Predicate Device | Predicate Device |
| 510(k) Number | | K171950 | K212631 |
| 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; MUW |
| Production Method | Lathe-cut | Lathe-cut | Lathe-cut |
| Material (USAN) | Roflufocon D<br>Roflufocon E<br>Hexafocon A<br>Hexafocon B<br>Tisilfocon A | Roflufocon D<br>Roflufocon E<br>Hexafocon A<br>Hexafocon B | Tisilfocon 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'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. |
| Visionary<br>Optics Scleral<br>Contact Lens | 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 |
| (Predicate<br>Device:<br>K171950) | dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant,<br>LASIK, radial keratotomy), and corneal scarring from infection or trauma. |
| Optimum<br>Infinite<br>Daily Wear<br>Contact Lenses<br>(Predicate<br>Device:<br>K212631) | 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. |
| | The Optimum Infinite (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily<br>wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or<br>hyperopia. |
| | The Optimum Infinite (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for<br>the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia<br>and/or possesses refractive astigmatism not exceeding 10.00 diopters. |
| | The Optimum Infinite (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is<br>indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes<br>with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring<br>add power of up to +4.00 diopters. |
| | The Optimum Infinite (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in<br>otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions<br>such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK)<br>surgery. |
| | The Optimum Infinite (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an<br>orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To<br>maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. |
| | Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous<br>hydrated environment and the saline bath provided by scleral lens designs.<br>Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of irregular<br>and distorted corneal surfaces where the subject: |
| | 1. cannot be adequately corrected with spectacle lenses |
| | 2. requires a rigid gas permeable contact lens surface to improve vision |
| | 3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities |
| Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar<br>formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also<br>include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular<br>degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers<br>dystrophy, Cogan's dystrophy). | |
| The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface<br>disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome and Filamentary Keratitis), limbal<br>stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g.<br>atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and<br>corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and<br>protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface<br>disease, the Optimum Infinite (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error. | |
| Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and<br>scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and<br>disinfected using a chemical (not heat) lens care system. | |

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#### 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 and tisilfocon A has been addressed by reference to previous 510(k) clearances.

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

Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Visionary Optics LLC to manufacture lenses, on a repeatable basis, from 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 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.

~ 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.

~ 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) 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 B, tisilfocon 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.