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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceVISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantVistakon, Division of Johnson & Johnson Vision Car
7500 Centurion Pkwy.
Suite 100 - Erca
Jacksonville, FL 32256
PMA NumberP040045
Date Received11/15/2004
Decision Date12/20/2005
Product Code LPM 
Docket Number 05M-0504
Notice Date 12/27/2005
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER. THE DEVICE IS INDICATED FOR USE AS FOLLOWS: THE VISTAKON (SENOFILCON A) SOFT CONTACT LENS (SPHERICAL) IS INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO HAVE 1.00D OR LESS OF ASTIGMATISM. THE VISTAKON (SENOFILCON A) MULTIFOCAL SOFT CONTACT LENS IS INDICATED FOR THE OPTICAL CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC, PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY HAVE 0.75D OF ASTIGMATISM OR LESS. THE VISTAKON (SENOFILCON A) TORIC SOFT CONTACT LENS IS INDICATED FOR THE OPTICAL CORRECTION OF VISUAL ACUITY IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE HYPEROPIC OR MYOPIC AND MAY HAVE 10.00D OF ASTIGMATISM OR LESS. THE VISTAKON (SENOFILCON A) MULTIFOCAL-TORIC SOFT CONTACT LENS IS INDICATED FOR THE OPTICAL CORRECTION OF DISTANCE AND NEAR IN PRESBYOPIC PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY HAVE 10.00D OF ASTIGMATISM OR LESS. THE VISTAKON (SENOFILCON A) UV BLOCKING SOFT CONTACT LENS HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE. EYE CARE PROFESSIONALS MAY PRESCRIBE THE LENSES EITHER FOR SINGLE-USE DISPOSABLE WEAR OR FREQUENT/PLANNED REPLACEMENT WEAR WITH CLEANING, DISINFECTION AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR THE LENSES MAY BE CLEANED AND DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM ONLY. VISTAKON (SENOFILCON A) CONTACT LENSES MAY BE PRESCRIBED FOR DAILY WEAR AND EXTENDED WEAR FOR UP TO 6 NIGHTS/7 DAYS OF CONTINUOUS WEAR. IT IS RECOMMENDED THAT THE CONTACT LENS WEARER FIRST BE EVALUATED ON A DAILY WEAR SCHEDULE. IF SUCCESSFUL, THEN A GRADUAL INTRODUCTION OF EXTENDED WEAR CAN BE FOLLOWED AS DETERMINED BY THE PRESCRIBING EYE CARE PROFESSIONAL.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S019 S020 S021 S022 S023 S024  S018 S035 S036 S037 S025 
S026 S027 S002 S003 S062 S063 S064 S057 S069 S070 S011 S015 
S012 S013 S009 S017 S004 S005 S006 S014 S056 S077 S071 S072 
S073 S074 S075 S076 S065 S066 S067 S068 S058 S059 S060 S061 
S088 S089 S090 S100 S096 S081 S082 S117 S118 S109 S113 S114 
S102 S125 S126 S127 S122 S130 S121 S132 S133 S137 S099 S098 
S091 S083 S084 S085 S086 S087 S092 S093 S094 S095 S078 S079 
S080 S097 S101 S105 S106 S110 S135 S136 S139 S142 S143 S144 
S001 S010 S028 S030 S052 S053 S054 S045 S046 S042 S048 S041 
S050 S051 S031 S032 S033 S007 S008 S039 S047 S115 S116 S034 
S049 S119 S120 S112 S107 S108 S103 S104 S141 S123 S043 S044 
S124 S129 S128 S040 S131 S140 S134 S055 S138 
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