Search Results

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.

Ask a specific question about this device