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: O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
• Classification Name: lenses, soft contact, extended wear
• Generic Name: extended wear soft contact lenses
• Regulation Number: 886.5925
• Applicant: CIBA VISION CORPORATION
• PMA Number: P010019
• Supplement Number: S003
• Date Received: 06/08/2004
• Decision Date: 09/27/2004
• Product Code: LPM [ Registered Establishments with LPM ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: design change - minor
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for 1) a modification to the lotrafilcon a material to market lotrafilcon b contact lenses with an indication for up to 6 nights of extended wear; 2) incorporation of a light blue handling tint, copper phthalocyanine, to both the lotrafilcon a and lotrafilcon b lens materials; and 3) a labeling change for lotrafilcon a lenses to allow for use with enzymatic cleaners. The lotrafilcon b lens will be marketed under the trade name o2 optix (lotrafilcon b) soft contact lenses for extended wear and is indicated for the following: o2 optix (lotrafilcon b) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1. 50 diopters (d) of astigmatism that does not interfere with visual acuity. O2 optix toric (lotrafilcon b) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to 6. 00 d or less of astigmatism. O2 optix progressive (lotrafilcon b) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3. 00 d or less and who may have up to approximately 1. 50 d of astigmatism. O2 optix progressive toric (lotrafilcon b) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 0. 75 to 2. 75 d of refractive and/or corneal astigmatism. The lenses may be prescribed for daily wear or extended wear for up to 6 nights of continuous wear with removal for disposable, or cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care prof.