PMA P850077S023

Device: SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS
Applicant: CooperVision, Inc.
PMA number: P850077
Supplement: S023
Product code: LPM
Decision date: 1997-05-19
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: APPROVAL FOR AN ALTERNATE MOLDED LENS MANUFACTURING PROCESS FOR A MULTIFOCAL LENS DESIGN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNSOFT MULTIPLES(TM) AND IS INDICATED FOR DIALY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE PRESBYOPIC, WITH OR WITHOUT ASSOCIATED AMETROPIA. THE LENS MAY BE WORN BY PERSONS WHO REQUIRE UP TO +3.00 DIOPTERS (D) OF ADD AND WHO EXHIBIT REFRACTIVE ASTIGMATISM OF NO MORE THAN 1.50 D THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS RANGES IN SPHERICAL POWER FROM -20.00D TO +10.00 D.

Current openFDA PMA Record#

Device: SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS
Applicant: CooperVision, Inc.
PMA number: P850077
Supplement: S023
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1997-05-19
Decision code: APPR
Date received: 1997-04-16
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 FOR A MULTIFOCAL LENS DESIGN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNSOFT MULTIPLES(TM) AND IS INDICATED FOR DIALY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE PRESBYOPIC, WITH OR WITHOUT ASSOCIATED AMETROPIA. THE LENS MAY BE WORN BY PERSONS WHO REQUIRE UP TO +3.00 DIOPTERS (D) OF ADD AND WHO EXHIBIT REFRACTIVE ASTIGMATISM OF NO MORE THAN 1.50 D THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS RANGES IN SPHERICAL POWER FROM -20.00D TO +10.00 D.