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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.
 
DeviceFRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP830037
Supplement NumberS045
Date Received03/28/2002
Decision Date05/01/2002
Withdrawal Date02/27/2019
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE OF TINT FROM PHTHALOCYANINE GREEN TO CARBAZOLE VIOLET FOR FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) UV SOFT (HYDROPHILIC) CONTACT LENSES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATION: FRESHLOOK SPHERICAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO 2.0 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. FRESHLOOK TORIC (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO 6.0 DIOPTERS. FRESHLOOK BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY AND PRESBYOPIA IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO .75 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENSES MAY BE PRESCRIBED FOR EXTENDED WEAR IN NOT-APHAKIC PERSONS FROM 1-7 DAYS BETWEEN REMOVAL FOR CLEANING AND DISINFECTION OR DISPOSAL, AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THE EYE CARE PRACTITIONER MAY PRESCRIBE THE LENS IN EITHER A SINGLE USE DISPOSABLE PROGRAM OR IN A FREQUENT REPLACEMENT PROGRAM WITH CLEANING, DISINFECTION, AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED IN A FREQUENT REPLACEMENT PROGRAM, THE LENS MAY BE DISINFECTED USING A CHEMICAL (HOT HEAT) DISINFECTION SYSTEM. FRESHLOOK LENSES WITH UV ABSORBING MONOMER HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.
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