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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN
Generic NameLenses, soft contact, daily wear
ApplicantCOOPER VISION, INC.
6150 Stoneridge Mall Road
Suite 370
Pleasanton, CA 94588
PMA NumberP850077
Supplement NumberS022
Date Received11/22/1996
Decision Date03/10/1997
Withdrawal Date 05/01/2014
Product Codes LPL LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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.
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