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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 DIMENSIONS (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/6 NIGHTS (SPHERICAL
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP830037
Supplement NumberS048
Date Received02/07/2003
Decision Date03/06/2003
Withdrawal Date 02/27/2019
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE FRESHLOOK DIMENSIONS (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENS INDICATED FOR EXTENDED WEAR UP TO 6 NIGHTS/7 DAYS. THIS DEVICE WILL BE AN OPTIMIZED COMBINATION OF TWO OF THE PREVIOUSLY APPROVED PROCESSES; NAMELY, CURRENT FRESHLOOK COLORBLENDS (MULTIPLE PRINT) PRINTING PROCESS (P830037/S045) AND THE FRESHLOOK HANDLING TINT MONOMER TINTING PROCESS (830037/S039). THIS ADDITIONAL PROCESS OF PRINTING ONTO A TINTED LENS FOR THE FRESHLOOK (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FAMILY OFFERS THE PATIENT A CONTACT LENS OPTION WITH A BETTER CONTRAST IN THE PRINTED PORTION OF THE LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE FRESHLOOK TRADE NAME WITH THE FOLLOWING INDICATION: FRESHLOOK DIMENSIONS (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. THE LENS ACTS TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE. 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. THE LENS ACTS TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE. 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 DISINFECTION SYSTEM. FRESHLOOK SOFT CONTACT LENSES WITH UV ABSORBING MONOMER HELP PROTECT...
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