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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.
 
DeviceMETHAFILCON A
Generic NameLenses, soft contact, extended wear
ApplicantCOOPERVISION, INC.
370 WOODCLIFF DRIVE
SUITE 200
FAIRPORT, NY 14450-0000
PMA NumberP850079
Supplement NumberS037
Date Received08/16/2000
Decision Date09/25/2000
Product Codes LPM MVN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FREQUENCY COLORS CONTACT LENSES IN PHERICAL, ASPHERIC AND TORIC CONFIGURATIONS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES FREQUENCY COLORS, FREQUENCY ASPHERIC COLORS AND FREQUENCY TORIC COLORS (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR. THE FREQUENCY COLORS, FREQUENCY ASPHERIC COLORS ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THEY ARE ALSO INDICATED TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE, INCLUDING OCULAR MASKING, EITHER IN SIGHTED OR NON-SIGHTED EYES THAT REQUIRE A PROSTHETIC CONTACT LENS FOR THE MANAGEMENT OF CONDITIONS SUCH AS CORNEAL, IRIS OR LENS ABNORMALITIES. THE LENS MAY ALSO BE PRESCRIBED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY OR FOR OCCLUSIVE THERAPY FOR CODITIONS SUCH AS DIPLOPIA, AMBLYOPIA OR EXTREME PHOTOPHOBIA. THE FREQUENCY TORIC COLORS LENSES ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THEY ARE ALSO INDICATED TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE, INCLUDING OCULAR MASKING, EITHER IN SIGHTED OR NON-SIGHTED EYES THAT REQUIRE A PROSTHETIC CONTACT LENS FOR THE MANAGEMENT OF CONDITIONS SUCH AS CORNEAL, IRIS OR LENS ABNORMALITIES. THE LENS MAY ALSO BE PRESCRIBED FOR THE CORRECTINO OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENSES MAY BE WORN BY PERSONS WHO HAVE ASTIGMATISM OF 12.00 DIOPTERS OR LESS OR FOR OCCLUSIVE THERAPY FOR CONDITIONS SUCH AS DIPLOPIA, AMBLYOPIA OR EXTREME PHOTOPHOBIA.
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