Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: ACUVUE 2 COLORS BRAND (ETAFILCON A) CONTACT LENS WITH UV BLOCKER
• Classification Name: lenses, soft contact, extended wear
• Generic Name: contact lenses
• Regulation Number: 886.5925
• Applicant: VISTAKON
• PMA Number: N18033
• Supplement Number: S035
• Date Received: 01/29/2001
• Decision Date: 04/12/2001
• Product Code: LPM [ Registered Establishments with LPM ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: change design/components/specifications - color additive
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for an etafilcon a soft (hydrophilic) contact lens for extended wear with uv blocker and the follwoing listed color additives: iron oxide black, iron oxide brown, iron oxide red, iron oxide yellow, titanium dioxide, phthalocyaninato (2-) copper, phthalocyanine green and vat orange 1. The device will be marketed with the following trade names and indicatnions: the acuvue (r) 2 colours contact lenses are indicated for daily wear to enhance or later the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1. 00d or less of astigmatism. The acuvue(r) 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 non-aphakic persons with non-diseased eyes who may have 0. 75d of astigmatism or less. The acuvue(r) 2 colours (etafilcon a) soft (hydrophilic) toric contact lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10. 00d of astigmatism or less. The acuvue(r) 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 non-aphakic persons with non-diseased who may have 10. 00d or astigmatism or less. Acuvue(r) 2 colours uv blocking contact lenses help protect against transmissino of harmful uv radiatino to the cornea and into the eye. The acutvue(r) 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 disinfectio.