PMA P960022S003

Device: SOFTLENS66 TORIC (ALPHAFILCON A)VISIBILITY TINTED CONTACT LENSES
Applicant: Bausch & Lomb, Inc.
PMA number: P960022
Supplement: S003
Product code: LPM
Decision date: 2003-04-04
Generic name: Lenses, soft contact, extended wear
Approval order statement: APPROVAL FOR A TORIC DESIGN WITH AN EXTENDED WEAR INDICATION FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR THE ABOVE REFERENCED DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB SOFLENS66 TORIC (ALPHAFILCONA) VISIBILITY TINTED CONTACT LENSES AND IS INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF UP TO 5.00 DIOPTERS (D) THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +6.00 D TO -9.00D WHEN PRESCRIBED FOR USE TO 7 DAYS OF EXTENDED WEAR.

Current openFDA PMA Record#

Device: SOFTLENS66 TORIC (ALPHAFILCON A)VISIBILITY TINTED CONTACT LENSES
Applicant: Bausch & Lomb, Inc.
PMA number: P960022
Supplement: S003
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2003-04-04
Decision code: APPR
Date received: 2003-03-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A TORIC DESIGN WITH AN EXTENDED WEAR INDICATION FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR THE ABOVE REFERENCED DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB SOFLENS66 TORIC (ALPHAFILCONA) VISIBILITY TINTED CONTACT LENSES AND IS INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF UP TO 5.00 DIOPTERS (D) THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +6.00 D TO -9.00D WHEN PRESCRIBED FOR USE TO 7 DAYS OF EXTENDED WEAR.