(108 days)
No.
The document describes contact lenses, which are physical devices used for vision correction. There is no mention of any computational processing, data analysis, or adaptive learning capabilities that would suggest the presence of an AI model.
No.
Explanation: The device is indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia, which are refractive errors, not diseases. It is not intended to treat, cure, mitigate, or prevent any disease.
No
The device is indicated for the correction of refractive ametropia and presbyopia, meaning it is a corrective lens, not one used for diagnosis.
No
The device is a contact lens, which is a physical device made of specified materials (ocufilcon D). The description details its physical properties, manufacturing process (molding, tinting, pad-printing), and its intended use for correcting vision by being placed on the eye. It is clearly a hardware medical device, not a software-only one.
No
The device is a contact lens intended for the correction of refractive ametropia. It does not perform an in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The SPHERICAL/ASPHERE Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The TORIC Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The MULTIFOCAL Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
Product codes
LPL, MVN
Device Description
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution with polymeric wetting agents. The color additive (Pathalocyaninto(2-))Copper, Iron Oxide and Reactive Yellow 15 are added to the lens material to create a light yellow-green edge-to-edge color to make it easier to see when handling, and additionally, reduce transmittance of short wavelength light in the range of 380nm to 460nm. In addition, lenses contain a benzotriazole monomer to filter UVA and UVB radiation. The (ocufilcon D) name has been adopted by the United States Adopted Names Council (USAN).
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are available tinted for visibility, and tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Reactive Yellow 15, Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green.
When producing the color lenses, the manufacturing process changes the specifications to the light yellow-green contact lens by pad-printing the color pigment(s)—entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses filter >95% in the UVB range (280nm - 315nm), and >80% in the UVA range (315nm - 380nm).
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are manufactured in the sphere/asphere, toric, and multifocal design configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye care practitioners
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 Testing: A series of preclinical testing was performed to demonstrate the safety and effectiveness of the Aurora (ocufilcon D) finished contact lenses. The results support the claim that the Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are substantially equivalent to the currently marketed predicate devices.
- Toxicology:
- In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 and the results indicate that the finished lens extracts, blister packaging material extracts, and primary packaging solution are not cytotoxic.
- Systemic Toxicity: Systemic injection test was performed in accordance with ISO 10993-11 and the results indicate that the finished lens extracts and blister packaging material extracts do not produce acute systemic toxicity.
- Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-23, and the results indicate that the finished lens extracts, blister packaging material extracts, and primary packaging solution do not produce ocular irritation.
- Shelf Life: Testing was performed to evaluate the stability, sterility, and package integrity of the Aurora (ocufilcon D) finished contact lenses over the duration of the labeled expiration date. The data presented supports substantial equivalence.
- Physicochemical & Mechanical Properties: The following tests were completed to verify substantial equivalence: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals. Results demonstrate consistent material properties.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
VizionFocus Inc.
℅ Bret Andre
Principal Consultant
Andre Vision and Device Research
6119 Canter Lane
West Linn, OR 97068
Re: K243953
Trade/Device Name: Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
Regulation Number: 21 CFR 886.5925
Regulation Name: Soft (Hydrophilic) Contact Lens
Regulatory Class: Class II
Product Code: LPL, MVN
Dated: December 17, 2024
Received: March 11, 2025
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.
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.
April 10, 2025
Page 2
April 10, 2025
VizionFocus Inc.
℅ Bret Andre
Principal Consultant
Andre Vision and Device Research
6119 Canter Lane
West Linn, OR 97068
Re: K243953
Trade/Device Name: Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
Regulation Number: 21 CFR 886.5925
Regulation Name: Soft (Hydrophilic) Contact Lens
Regulatory Class: Class II
Product Code: LPL, MVN
Dated: December 17, 2024
Received: March 11, 2025
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.
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.
K243953 - Bret Andre Page 2
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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-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/medical-devices/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.
Page 3
K243953 - Bret Andre Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 -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
Page 4
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Submission Number (if known): K243953
Device Name: Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
Indications for Use (Describe)
The SPHERICAL/ASPHERE Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The TORIC Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The MULTIFOCAL Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Page 5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 6
510 (k) SUMMARY
Page 1 of 8
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K243953
I. SUBMITTER
Date Prepared: April 10, 2025
Name: VIZIONFOCUS INC.
Address: No. 5, Renyi St., Zhunan Township
Miaoli County 350,
Taiwan (R.O.C.)
Contact Person: Angus Shih
General Manager
Phone number: 037-582900
Consultant: Bret Andre
EyeReg Consulting, Inc.
6119 Canter Ln.
West Linn, OR 97068
Phone number: (503) 372-5226
II. DEVICE
Trade Name: Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
Common Name: Contact Lens, Daily Wear
Classification Name: Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Regulatory Class: Class II
Product Code: LPL; MVN
Purpose of 510(k) Submission:
~ New Device ~
Page 7
Page 2 of 8
III. PREDICATE DEVICE
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are substantially equivalent to the following predicate device(s):
- "ILICON (ocufilcon D)"
By VIZIONFOCUS INC.
510(k) number; K182247
IV. DEVICE DESCRIPTION
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution with polymeric wetting agents. The color additive (Pathalocyaninto(2-))Copper, Iron Oxide and Reactive Yellow 15 are added to the lens material to create a light yellow-green edge-to-edge color to make it easier to see when handling, and additionally, reduce transmittance of short wavelength light in the range of 380nm to 460nm. In addition, lenses contain a benzotriazole monomer to filter UVA and UVB radiation. The (ocufilcon D) name has been adopted by the United States Adopted Names Council (USAN).
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are available tinted for visibility, and tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives:
| Color Additive | Listing |
|---|---|
| Reactive Yellow 15 | 21 CFR § 73.3121 |
| Rutile TiO2 | 21 CFR § 73.3126 |
| Iron Oxide | 21 CFR § 73.3125 |
| (Pathalocyaninto(2-))Copper | 21 CFR § 74.3045 |
| Carbazole Violet | 21 CFR § 73.3107 |
| Phthalocyanine Green | 21 CFR § 73.3124 |
When producing the color lenses, the manufacturing process changes the specifications to the light yellow-green contact lens by pad-printing the color pigment(s)—entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.
Page 8
Page 3 of 8
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses filter >95% in the UVB range (280nm - 315nm), and >80% in the UVA range (315nm - 380nm).
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are manufactured in the sphere/asphere, toric, and multifocal design configurations. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance* |
|---|---|---|
| Chord Diameter | 11.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.05 mm to 0.15 mm | When ≤ 0.10 mm ±0.010 mm + 10% |
| When > 0.10 mm ±0.015 mm + 5% | ||
| Base Curve | 7.00 mm to 10.0 mm | ±0.20 mm |
| Back Vertex Power (F'v) | +20.00D to -20.00D (in 0.25D steps) | When 0.00 1.50 D ± 5° |
| Multifocal Add Power | +0.25D to +4.00D (0.50D steps) | ±0.37 D |
| Surface Appearance | - | Lenses should be clear with no surface defect |
| Oxygen Permeability (x 10-11(cm2/sec)(mlO2)/(ml x mmHg))a | 19.6 | ±20% |
| Light Transmission - (@ 380-780nm) | 95% | ±5% |
| Light Transmission - (@ 380-460nm) | >75% | >75% |
| Ultraviolet Radiation Transmittance | 50% H2O, ionic polymer) |
- FDA classification – Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
- Intended use – daily wear contact lenses
- Actions
- Indications for use
- Design configurations available (spherical, toric, multifocal)
- UV absorber
- Cast molded production method
- Pad-printing contact lens tinting method (for color lenses)
Page 10
Page 5 of 8
The following matrix illustrates the production method, lens function and material characteristics of the Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color), as well as the predicate devices.
| | VIZIONFOCUS INC
Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
(Subject Device) | VIZIONFOCUS INC
ILICON
(Predicate Device) (K182247) |
|---|---|---|
| Actions | The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina | The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina |
| FDA Classification | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
| FDA Group | FDA Group 4 (>50% H2O, ionic polymer) | FDA Group 4 (>50% H2O, ionic polymer) |
| Production Method | Fully molded | Fully molded |
| USAN name | ocufilcon D | ocufilcon D |
| Water Content (%) | 55±2% | 55±2% |
| Oxygen Permeability x 10-11 (cm2/sec)(mlO2)/(ml x mmHg @ 35°C))a | 19.6 | 19.6 |
| Refractive Index (hydrated) | 1.410 | 1.410 |
| Modulus (MPa) | 0.49 | 0.49 |
| UV Blocker | Yes | Yes |
| Pad-Printed Tinting | Yes | Yes |
| Tinting color | Light yellow-green | Blue |
a (Polarographic method, edge corrected)
Page 11
Page 6 of 8
The following matrix compares the indications for use of the Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) with the predicate device.
Indications for Use
| Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
By Vizionfocus Inc.
(Subject Device) | ILICON (ocufilcon D) Soft (hydrophilic) Daily Wear Contact Lenses
By Vizionfocus Inc. (K182247) |
|---|---|
| The SPHERICAL / ASPHERE Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The TORIC Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The MULTIFOCAL Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal. | The ILICON (ocufilcon D) SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The ILICON (ocufilcon D) TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The ILICON (ocufilcon D) MULTIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or notaphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The ILICON (ocufilcon D) MULTIFOCAL TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 5.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal. |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Non-clinical Testing
A series of preclinical testing was performed to demonstrate the safety and effectiveness of the Aurora (ocufilcon D) finished contact lenses. The results support the claim that the Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are substantially equivalent to the currently marketed predicate devices. A summary of the results from the preclinical studies is presented below.
Toxicology:
All non-clinical toxicology tests were conducted in accordance with the GLP regulation.
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In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 and the results indicate that the finished lens extracts, blister packaging material extracts, and primary packaging solution are not cytotoxic.
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Systemic Toxicity: Systemic injection test was performed in accordance with ISO 10993-11 and the results indicate that the finished lens extracts and blister packaging material extracts do not produce acute systemic toxicity.
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Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-23, and the results indicate that the finished lens extracts, blister packaging material extracts, and primary packaging solution do not produce ocular irritation.
Shelf Life:
Testing was performed to evaluate the stability, sterility, and package integrity of the Aurora (ocufilcon D) finished contact lenses over the duration of the labeled expiration date. The data presented supports substantial equivalence of the contact lenses to the already marketed predicate devices.
Physicochemical & Mechanical Properties:
The following tests were completed to verify substantial equivalence: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistent material properties between the Aurora (ocufilcon D) contact lenses and the predicate device.
The results of the non-clinical testing on the subject device demonstrate that: the lens material and extracts are non-toxic and non-irritating, the lens specifications are stable for the duration of the labeled expiration date, and lens physical and material properties are consistent with currently marketed lenses.
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Clinical Testing
Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from (ocufilcon D) materials has been demonstrated previously.
VIII. CONCLUSIONS
Validity of Scientific Data
Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.
Substantial Equivalence
Information presented in this Premarket Notification establishes that the Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.
Risks and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft (hydrophilic) daily wear contact lenses.