FDA.reportPublic FDA data

PMA P010019S003

Device
O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S003
Product code
LPM
Decision date
2004-09-27
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
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.

Current openFDA PMA Record#

Device
O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S003
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2004-09-27
Decision code
APPR
Date received
2004-06-08
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
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.