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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.
 
DeviceACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL
Generic Namelens, multifocal intraocular
Regulation Number886.3600
Applicant
Alcon Research, Ltd.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP040020
Date Received04/19/2004
Decision Date03/21/2005
Product Code MFK 
Docket Number 05M-0117
Notice Date 04/12/2005
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
RecallsCDRH Recalls
Approval Order Statement 
APPROVAL FOR THE ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), MODELS MA60D3 AND SA60D3. THIS DEVICE IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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 S043 S044 
S045 S046 S047 S048 S049 S050 S051 S052 S053 
S054 S055 S056 S058 S059 S060 S061 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 S101 
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