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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.
 
DeviceSOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP910056
Date Received09/18/1991
Decision Date01/17/1992
Product Code HQL 
Docket Number 92M-0047
Notice Date 02/18/1992
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements: S010  S001 S002 S003 S006 S007 S008 S011 S012 S013 S014 
S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S026 S027 
S028 S029 S030 S031 S032 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S043 S044 S046 S048 S049 S050 S051 S053 S055 
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