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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 (R) UV ABSORBING INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALCON LABORATORIES, INC.
6201 SOUTH FREEWAY DR.
FORT WORTH, TX 76134
PMA NumberP930014
Date Received05/28/1993
Decision Date12/22/1994
Product Code HQL 
Docket Number 96M-0221
Notice Date 07/15/1996
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the ACRYSOf® Models MA60BM and MA30BA Ultraviolet-Absorbing Acrylic Foldable UV-Absorbing Posterior Chamber Intraocular Lenses (IOLs). These devices are indicated for replacement of the human lens to achieve visual correction of aphakia in patients 60 years of age and older when extracapsular cataract extraction or phacoemulsification are performed. These lenses are intended for placement in the capsular bag.
Supplements: S002 S003 S071 S072  S001 S004 S080 S067 S068 S086 S070 
S074 S059 S060 S061 S034 S035 S015 S013 S010 S037 S038 S039 
S032 S033 S029 S030 S031 S046 S011 S012 S040 S041 S009 S006 
S016 S018 S020 S091 S096 S097 S092 S093 S094 S095 S008 S005 
S075 S081 S082 S083 S065 S066 S078 S064 S073 S087 S088 S062 
S057 S058 S076 S077 S084 S085 S069 S079 S017 S014 S023 S026 
S027 S042 S043 S044 S045 S036 S028 S019 S022 S024 S025 S103 
S104 S089 S090 S098 S099 S101 S102 S133 S137 S138 S140 S141 
S135 S136 S145 S144 S123 S124 S125 S117 S118 S129 S130 S119 
S120 S121 S122 S134 S128 S116 S113 S114 S115 S111 S106 S107 
S108 S112 S109 S105 S142 S143 S139 S131 S132 S126 S127 S110 
S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 S063 
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