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: CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) SOFT CONTACT LENSES
• 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: S021
• Date Received: 03/01/2011
• Decision Date: 09/09/2011
• Product Code: LPM [ Registered Establishments with LPM ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: labeling change - trade name
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a trade name change to the (lotrafilcon b) soft contact lenses with wetting agent in package saline. The device, as modified, will be marketed under the trade name ciba vision air optix aqua (lotrafilcon b) and is indicated for the following: ciba vision air optix aqua (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 of astigmatism that does not interfere with visual acuity. Ciba vision air optix aqua (lotrafilcon b) toric 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 diopters (d) or less of astigmatism. Ciba vision air optix aqua (lotrafilcon b) multifocal 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 required a reading addition of +3. 00 diopters (d) or less and who may have up to approximately 1. 50 diopters of astigmatism. Ciba vision air optix aqua (lotrafilcon b) multifocal toric 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 10. 00 diopters (d) or less 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 disposal, or cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.