FDA.reportPublic FDA data

PMA P980006S012

Device
PUREVISION 2/PUREVISION 2 MULTI-FOCAL/PUREVISION 2 TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES
Applicant
Bausch & Lomb, Inc.
PMA number
P980006
Supplement
S012
Product code
LPM
Decision date
2008-05-30
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
APPROVAL FOR DECREASING THE CENTER THICKNESS OF THE PUREVISION LENS AND ADDING 0.3 WT% HYDROXYPROPYL METHYLCELLULOSE TO THE PACKING SOLUTION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PUREVISION 2 VISIBILITY TINTED CONTACT LENSES AND IS INDICATED FOR THE FOLLOWING APPROVED INDICATIONS FOR USE: VISION CORRECTION THE BAUSCH & LOMB PUREVISION 2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENS IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 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 AND HYPEROPIA) IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF 2.00 DIOPTERS OR LESS, 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 +8.00D TO ?20.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO ?20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS. THE BAUSCH & LOMB PUREVISION 2 MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 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) AND PRESBYOPIA IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF UP TO 2.00 DIOPTERS OR LESS, 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 +6.00D TO -18.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO ?20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS WITH ADD POWERS RANGING FROM +0.75D TO +5.00D.. (SEE APPROVAL ORDER FOR ADDITIONAL INFORMATION)

Current openFDA PMA Record#

Device
PUREVISION 2/PUREVISION 2 MULTI-FOCAL/PUREVISION 2 TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES
Applicant
Bausch & Lomb, Inc.
PMA number
P980006
Supplement
S012
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2008-05-30
Decision code
APPR
Date received
2008-04-02
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR DECREASING THE CENTER THICKNESS OF THE PUREVISION LENS AND ADDING 0.3 WT% HYDROXYPROPYL METHYLCELLULOSE TO THE PACKING SOLUTION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PUREVISION 2 VISIBILITY TINTED CONTACT LENSES AND IS INDICATED FOR THE FOLLOWING APPROVED INDICATIONS FOR USE: VISION CORRECTION THE BAUSCH & LOMB PUREVISION 2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENS IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 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 AND HYPEROPIA) IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF 2.00 DIOPTERS OR LESS, 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 +8.00D TO ?20.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO ?20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS. THE BAUSCH & LOMB PUREVISION 2 MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 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) AND PRESBYOPIA IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF UP TO 2.00 DIOPTERS OR LESS, 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 +6.00D TO -18.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO ?20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS WITH ADD POWERS RANGING FROM +0.75D TO +5.00D.. (SEE APPROVAL ORDER FOR ADDITIONAL INFORMATION)