(210 days)
Not Found
No
The summary describes a rigid gas permeable contact lens made of a specific material and available in various designs. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The clinical study focuses on the material's safety and effectiveness for therapeutic use.
Yes
The document explicitly states that "Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces" and "The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease."
No
The device is a contact lens intended for correcting refractive errors and for therapeutic management of certain eye conditions, not for diagnosing conditions.
No
The device description clearly states it is a physical contact lens made from a specific material (siloxanyl fluoromethacrylate copolymer) and includes details about its physical properties, manufacturing process, and available configurations. This indicates it is a hardware medical device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Optimum Infinite contact lenses are physical devices worn on the eye to correct vision problems (refractive error, astigmatism, presbyopia) and manage certain ocular surface conditions. They do not analyze biological samples to provide diagnostic information.
- Intended Use: The intended use clearly describes the lenses as being for the correction of refractive error and therapeutic management of ocular conditions, not for diagnosing any disease or condition.
- Device Description: The device description focuses on the material composition, manufacturing process, and physical properties of the contact lenses. There is no mention of reagents, assays, or any components typically associated with IVD tests.
Therefore, the Optimum Infinite contact lens is a medical device, but it falls under the category of ophthalmic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Optimum Infinite (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia.
The Optimum Infinite (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.
The Optimum Infinite (tisilfocon A) MULTIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Optimum Infinite (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
The Optimum Infinite (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To 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 hydrated environment and the saline bath provided by scleral lens designs.
Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for the management of irregular and distorted corneal surfaces where the subject:
-
- cannot be adequately corrected with spectacle lenses
-
- requires a rigid gas permeable contact lens surface to improve vision
-
- 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 linfections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome and Filamentary Keratis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratiis (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 a distorted cornea or ocular surface disease, the Optimum Infinite (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error.
Product codes
HQD, MUW
Device Description
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process.
In the Optimum Infinite (tisilfocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block >99% of UV radiation in the UVB range (280mm - 315nm) and >85% in the UVA range (316 - 380nm).
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses incorporate a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17.
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of up to 5.00 diopters in nondiseased eyes.
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be treated to incorporate Tangible TM Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material (tisilfocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness. The following table depicts the contact angle of the coated vs. uncoated lenses:
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the Optimum Infinite (tisilfocon A) Daily Wear Contact Lens is the PolyVial Contact Lens Case. When shipped "wet", the Optimum Infinite (tisilfocon A) Daily Wear Contact Lens may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.
The physical properties of the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are as follows:
Refractive Index (dry): 1.4378 (Hyper GP (tisilfocon A)), 1.4398 (Hyper GP (tisilfocon A) with Tangible™ Hydra-PEG)
Light Transmission (@380-780nm): 91.694 (Hyper GP (tisilfocon A)), 93.427 (Hyper GP (tisilfocon A) with Tangible™ Hydra-PEG)
UVA Transmission (@316-380nm): 14.241 (Hyper GP (tisilfocon A)), 16.105 (Hyper GP (tisilfocon A) with Tangible™ Hydra-PEG)
UVB Transmission (@280-315nm): 0.011 (Hyper GP (tisilfocon A)), 0.020 (Hyper GP (tisilfocon A) with Tangible™ Hydra-PEG)
Oxygen Permeability (Dk) ISO/FATT Method: 180 x 10^-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) for both
Visitint lenses contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17 for both.
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:
Parameter: Base Curve, Range: 4.00mm to 12.00mm, Tolerance: ± 0.05 mm
Parameter: Center Thickness, Range: Varies, Tolerance: ± 0.02 mm
Parameter: Chord Diameter, Range: 7.00mm to 22.00mm, Tolerance: ± 0.10mm
Parameter: Spherical Power, Range: -30.00 D to +30.00 D (in 0.25D steps), Tolerance: ± 0.12 (0 to = 5D), ± 0.18 (5 to = 10.0D), ± 0.25 (10 to = 15D), ± 0.37 (15 to = 20D), ± 0.50 (over 20D)
Parameter: Cylindrical Power, Range: Up to -10.00 D (in 0.25 D steps), Tolerance: ± 0.25 (0 to = 2D), ± 0.37 (2 to = 4D), ± 0.50 (over 4D)
Parameter: Cylindrical Axis, Range: 1° to 180° (in 1° steps), Tolerance: ± 5°
Parameter: Multifocal Power, Range: +1.00 D to 4.00 D (in 0.25 D steps), Tolerance: ± 0.25D
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses for daily wear orthokeratology is available in following lens parameters:
Parameter: Base Curve (BC), Range: 4.0mm to 12.00mm, Tolerance: ± 0.05 mm
Parameter: Center Thickness, Range: 0.10mm to 0.70mm, Tolerance: ± 0.02 mm
Parameter: Diameter, Range: 6.50mm to 11.50mm, Tolerance: ±0.10mm
Parameter: Secondary Curves, Range: 0.10mm to 2.00mm (flatter or steeper than BC), Tolerance: ±0.10mm
Parameter: Peripheral Curves, Range: 0.10mm to 2.00mm (flatter or steeper than BC), Tolerance: ±0.10mm
Parameter: Spherical Power, Range: -10.00 D to +3.00 D (in 0.25D steps), Tolerance: ± 0.12 (0 to = 5D), ± 0.18 (5 to = 10.0D), ± 0.25 (10 to = 15D), ± 0.37 (15 to = 20D), ± 0.50 (over 20D)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes, Cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare practitioners. The lenses are for prescription use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies: Non-clinical testing to demonstrate the safety and effectiveness of the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses have been addressed through previously cleared 510(k) premarket notifications.
Clinical Studies: Six (6) independent practitioners evaluated 62 patients (115 total eyes) presenting with various conditions therapeutically managed using scleral contact lenses manufactured from Optimum Infinite (tisilfocon A) material. The practitioners were instructed to review all patients treated with the Optimum Infinite (tisilfocon A) scleral contact lenses for at least 3 months, and to report 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. Fifty-five (55) of the eyes were treated for irregular cornea, whilst 62 eyes involved management of ocular surface disease. There were no serious or significant adverse reactions reported. For all patients, the ocular condition(s) and vision remained stable or improved during management with the Optimum Infinite (tisilfocon A) scleral contact lenses. The successful therapeutic fitting of 115 eyes over a total of 15,017 days without any serious adverse reaction reported supports the conclusion that the Optimum Infinite (tisilfocon A) scleral contact lenses are safe and effective for therapeutic management of ocular surface diseases and irregular corneal conditions.
Key results: The successful therapeutic fitting of 115 eyes over a total of 15,017 days without any serious adverse reaction reported supports the conclusion that the Optimum Infinite (tisilfocon A) scleral contact lenses are safe and effective for therapeutic management of ocular surface diseases and irregular corneal conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K182304, K180616, K161461, K172314
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5916 Rigid gas permeable contact lens.
(a)
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.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 17, 2022
Contamac Ltd. % Bret Andre Consultant EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068
Re: K212631
Trade/Device Name: Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD, MUW Dated: February 4, 2022 Received: February 7, 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.
1
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 entitled, "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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212631
Device Name
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
Indications for Use (Describe)
The Optimum Infinite (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia.
The Optimum Infinite (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.
The Optimum Infinite (tisilfocon A) MULTIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Optimum Infinite (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
The Optimum Infinite (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To 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 hydrated environment and the saline bath provided by scleral lens designs.
Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for the management of irregular and distorted corneal surfaces where the subject:
-
- cannot be adequately corrected with spectacle lenses
-
- requires a rigid gas permeable contact lens surface to improve vision
-
- 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 linfections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome and Filamentary Keratis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratiis (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 a distorted cornea or ocular surface disease, the Optimum Infinite (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error.
3
Eyecare 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K212631
I. SUBMITTER
-
March 9th, 2022 Date Prepared:
Contamac Ltd. Name: Address: Carlton House Shire Hill Saffron Walden Essex CB11 3AU Contact Person: Robert McGregor -
Managing Director Phone number: 01799 514800
| Consultant: | Bret Andre |
|---|---|
| EyeReg Consulting, Inc | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 | |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade Name: | Optimum Infinite (tisilfocon A) Daily Wear Contact Lens |
|---|---|
| Common | |
| Name: | Daily wear rigid gas permeable contact lens |
| Classification | |
| Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| Regulatory | |
| Class: | Class II |
| Product Code: | HQD; MUW |
| Reason for Submission~ | New Indications for Use |
Reason for Submission
5
III. PREDICATE DEVICE
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are substantially equivalent to the following predicate devices:
- l "Hyper GP (tisilfocon A) Daily Wear Contact Lens" By Contamac Ltd. 510(k) number; K182304
- "OPTIMUM GP (roflufocon D, roflufocon E) Daily Wear Contact Lens; HEXA100 (hexafocon A) Daily Wear Contact Lens" By Contamac Ltd. 510(k) number: K180616
- . "BostonSight PD Prosthetic Device" Manufactured by Boston Foundation for Sight 510(k) number: K161461
- I "Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)" By Art Optical Contact Lens, Inc. 510(k) number; K172314
IV. DEVICE DESCRIPTION
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process.
In the Optimum Infinite (tisilfocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block >99% of UV radiation in the UVB range (280mm - 315nm) and >85% in the UVA range (316 - 380nm).
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses incorporate a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17.
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of up to 5.00 diopters in nondiseased eyes.
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be treated to incorporate Tangible TM Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material (tisilfocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness. The following table depicts the contact angle of the coated vs. uncoated lenses:
6
| Hyper GP tisilfocon A | ||
|---|---|---|
| Uncoated | Tangible™ Hydra-PEG | |
| Coated | ||
| Average Sessile Drop Contact Angle | ||
| (degrees) n=30 | 106.2 | 37.34 |
| Standard Deviation | 5.31 | 5.30 |
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the Optimum Infinite (tisilfocon A) Daily Wear Contact Lens is the PolyVial Contact Lens Case. When shipped "wet", the Optimum Infinite (tisilfocon A) Daily Wear Contact Lens may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.
The physical properties of the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are as follows:
| | Hyper GP (tisilfocon A) | Hyper GP (tisilfocon A) with
Tangible™ Hydra-PEG |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Refractive Index (dry) | 1.4378 | 1.4398 |
| Light Transmission (@380-780nm) | 91.694 | 93.427 |
| UVA Transmission (@316-380nm) | 14.241 | 16.105 |
| UVB Transmission (@280-315nm) | 0.011 | 0.020 |
| Oxygen Permeability
(Dk)
ISO/FATT Method | $180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @
35°C) | $180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @
35°C) |
| Visitint lenses contain one or more of the
following color additives conforming to:
21 CFR Part 73 & 74, Subpart D | D&C Green No. 6, C.I. Solvent
Yellow No. 18, D&C Violet No. 2 and
D&C Red No. 17 | D&C Green No. 6, C.I. Solvent
Yellow No. 18, D&C Violet No. 2
and D&C Red No. 17 |
The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 4.00mm to 12.00mm | $\pm$ 0.05 mm |
| Center Thickness | Varies | $\pm$ 0.02 mm |
| Chord Diameter | 7.00mm to 22.00mm | $\pm$ 0.10mm |
| Spherical Power | -30.00 D to +30.00 D | |
| (in 0.25D steps) | $\pm$ 0.12 (0 to = 5D) |