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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.
 
DeviceAIR OPTIX NIGHT & DAY AQUA (LOTRAFILCON A) 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 NumberS025
Date Received06/06/2011
Decision Date11/02/2011
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
Approval Order Statement  
APPROVAL FOR A TRADE NAME CHANGE TO THE SPHERICAL (LOTRAFILCON A) SOFT CONTACT LENSES WITH WETTING AGENT (L% COPOLYMER 845) IN PACKAGE SALINE, AND THE ADDITION OF DESCRIPTIVE TEXT FOR SYMBOLS APPEARING ON THE CARTONS, EXCEPT THE RX SYMBOL USED FOR "PRESCRIPTION USE," AS WELL AS THE TRADE NAME CHANGES TO ALL THE LOTRAFILCON A LENS DESIGNS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAMES: SPHERICAL - AIR OPTIX NIGHT & DAY AQUA; TORIC - AIR OPTIX NIGHT & DAY AQUA ASTIGMATISM; MULTIFOCAL - AIR OPTIX NIGHT & DAY AQUA MULTIFOCAL; AND MULTIFOCAL TORIC - AIR OPTIX NIGHT & DAY AQUA MULTIFOCAL TORIC AND IS INDICATED FOR THE FOLLOWING:AIR OPTIXC NIGHT & DAY AQUA (LOTRAFILCON A) 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 WHO HAVE 1.50 DIOPTERS OR LESS OF ASTIGMATISM. AIR OPTIX NIGHT & DAY AQUA FOR ASTIGMATISM (LOTRAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO HAVE 6.00 DIOPTERS (D) OR LESS OF ASTIGMATISM.AIR OPTIX NIGHT & DAY AQUA MULTIFOCAL (LOTRAFILCON A) 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 READINGADDITION OF +4.00 DIOPTERS (D) OR LESS AND WHO HAVE 1.50 DIOPTERS OR LESS OF ASTIGMATISM...(SEE APPROVAL ORDER FOR ADDITIONAL STATEMENT DETIAL)
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