(35 days)
The ACUVUE® 2 COLOURS Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC-BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.
ACUVUE® 2 COLOURS UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The ACUVUE 2 COLOURS Contact Lenses may be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see "Wearing Schedule"). When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
The device description is identical to that cleared under K010114.
The provided document is a 510(k) summary for a contact lens, ACUVUE® 2 COLOURS™ Brand (etafilcon A) soft (hydrophilic) contact lenses with UV blocker. It is a submission for substantial equivalence to a previously cleared device (K010114) and does not contain a study proving the device meets specific acceptance criteria.
Instead, it states that:
- The device description, intended use, and technological characteristics are identical to the predicate device.
- Non-clinical tests were conducted as recommended by the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994, and are included in PMA N18-033/S038. These tests include:
- Toxicology Testing
- Cytotoxicity
- USP Ocular Irritation
- USP Systemic Injection
- Leachable Monomer and Additive
- Physical/Chemical Testing
- Stability Testing
- Clinical data is not required for this submission.
Therefore, I cannot provide the information requested in your prompt as it pertains to a study demonstrating specific device performance against acceptance criteria. The document is a regulatory submission for substantial equivalence based on the device being identical to an already approved device and non-clinical testing.
§ 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.