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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: S067 S048 S049 S050 S051 S054 S055 S056  S001 S002 S003 
S004 S080 S063 S047 S091 S071 S072 S062 S086 S020 S037 S038 
S010 S034 S035 S029 S014 S026 S027 S005 S011 S012 S013 S024 
S025 S022 S016 S015 S018 S092 S093 S094 S095 S098 S099 S101 
S102 S008 S006 S052 S053 S060 S061 S064 S065 S066 S068 S075 
S081 S082 S083 S073 S078 S070 S087 S088 S076 S077 S084 S085 
S057 S058 S059 S074 S079 S017 S023 S030 S039 S042 S043 S044 
S045 S028 S009 S031 S036 S046 S019 S032 S033 S040 S041 S096 
S089 S090 S104 S097 S103 S069 S110 S105 S121 S122 S133 S127 
S128 S117 S118 S134 S137 S138 S135 S136 S106 S112 S107 S108 
S111 S109 S123 S124 S125 S126 S129 S119 S120 S130 S131 S132 
S113 S114 S115 S116 S145 S144 S142 S143 S146 S147 S140 S141 
S139 
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