Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBIOFINITY (COMFILCON A)
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Road, Suite 500
San Ramon, CA 94583
PMA NumberP080011
Date Received04/07/2008
Decision Date11/19/2008
Product Code LPM 
Docket Number 08M-0608
Notice Date 11/26/2008
Advisory Committee Ophthalmic
Clinical TrialsNCT00597467
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THEBIOFINITY (COMFILCON A) SOFT CONTACT LENS. THIS DEVICE IS INDICATED FOR USE AS FOLLOWS:BIOFINITY (COMFILCON A) SPHERE AND ASPHERC SOFT CONTACT LENSES ARE INDICATED FOR THECORRECTION OF AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS. THE LENSES MAY BE WORN BYPERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITHVISUAL ACUITY.BIOFINITY (COMFILCON A) TORIC SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OFAMETROPIA (MYOPIA OR HYPEROPIA WITH ASTIGMATISM) IN APHAKIC AND NON-APHAKIC PERSONSWITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS AND ASTIGMATICCORRECTIONS FROM -0.25 TO -5.00 DIOPTERS.BIOFINITY (COMFILCON A) MULTIFOCAL SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) AND EMMETROPIA WITH PRESBYOPIA INAPHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS WITH ADD POWERS FROM +0.50 TO +3.00 DIOPTERS. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.BIOFINITY (COMFILCON A) CONTACT LENSES MAY BE PRESCRIBED FOR EXTENDED WEAR FOR UP TO 6 NIGHTS AND 7 DAYS OF CONTINUOUS WEAR. IT IS RECOMMENDED THAT THE CONTACT LENS WEARER BE FIRST EVALUATED ON A DAILY WEAR SCHEDULE PRIOR TO OVERNIGHT WEAR. THE LENSES MAY BEPRESCRIBED FOR EITHER ONE WEEK DISPOSABLE WEAR OR FOR FREQUENT REPLACEMENT WITH CLEANING,DISINFECTION AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED FOR FREQUENT REPLACEMENT, THELENSES MUST BE CLEANED AND DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM ONLY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 
S036 S037 S038 S039 S040 S041 S042 S044 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 
S061 S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 
S073 S074 S075 S076 S077 S078 S079 S080 S081 S082 S083 S084 
S085 S086 S087 S088 S089 S090 S091 S092 S093 S094 S095 S096 
S097 S098 S099 S100 S102 S103 S104 S105 S106 S107 S108 S109 
S110 S111 S112 S113 S114 S115 S116 S117 S118 S119 S120 S121 
S122 S123 S124 S125 S126 S127 S128 S129 S130 S131 S132 S133 
S134 S136 S137 S138 S139 S140 S141 S142 S143 S144 S145 S146 
S147 S148 S149 S150 S151 S152 S153 S154 S155 S156 S157 S158 
S159 S160 S161 S162 
-
-