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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) SOFT CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP010019
Supplement NumberS021
Date Received03/01/2011
Decision Date09/09/2011
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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.
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