FDA.reportPublic FDA data

PMA P850077S022

Device
SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN
Applicant
CooperVision, Inc.
PMA number
P850077
Supplement
S022
Product code
LPL
Decision date
1997-03-10
Classification
Lenses, Soft Contact, Daily Wear
Generic name
Lenses, soft contact, daily wear
Approval order statement
APPROVAL FOR AN ALTERNATE MOLDED LENS MANUFACTURING PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNSOFT MULTIPLES(TM) AND ARE INDICATED AS FOLLOWS: 1)MULTIPLES TORIC LENSES ARE INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSON WITH NONDISEASED EYES THAT ARE MYOPIC OR HYPEROPIC AND AHVE REFRACTIVE ASTIGMATISM NOT EXCEEDING 7.00 DIOPTERS (D). 2) MULTIPLES SPHERICAL LENSES ARE INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NONDISEASED EYES THAT ARE MYOPIC OR HYPEROPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 1.50 D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENSES RANGE IN POWER FROM -20.00 D TO +10.00 D. 3) MULTIPLES APHAKIC LENSES ARE INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC PERSONS WITH NONDISEASED EYES THAT ARE HYPEROPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 1.50 D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENSES RANGE IN POWER FROM +10.50 D TO +20.00 D.

Current openFDA PMA Record#

Device
SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN
Applicant
CooperVision, Inc.
PMA number
P850077
Supplement
S022
Product code
LPL
Generic name
Lenses, soft contact, daily wear
Decision date
1997-03-10
Decision code
APPR
Date received
1996-11-22
Supplement type
Normal 180 Day Track
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR AN ALTERNATE MOLDED LENS MANUFACTURING PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNSOFT MULTIPLES(TM) AND ARE INDICATED AS FOLLOWS: 1)MULTIPLES TORIC LENSES ARE INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSON WITH NONDISEASED EYES THAT ARE MYOPIC OR HYPEROPIC AND AHVE REFRACTIVE ASTIGMATISM NOT EXCEEDING 7.00 DIOPTERS (D). 2) MULTIPLES SPHERICAL LENSES ARE INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NONDISEASED EYES THAT ARE MYOPIC OR HYPEROPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 1.50 D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENSES RANGE IN POWER FROM -20.00 D TO +10.00 D. 3) MULTIPLES APHAKIC LENSES ARE INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC PERSONS WITH NONDISEASED EYES THAT ARE HYPEROPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 1.50 D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENSES RANGE IN POWER FROM +10.50 D TO +20.00 D.