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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.
 
DeviceCOLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantSTARR SURGICAL CO.
1911 WALKER AVE.
MONROVIA, CA 91016
PMA NumberP990013
Date Received03/05/1999
Decision Date04/02/2000
Product Code HQL 
Docket Number 00M-1230
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
This device is indicated for the correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsification cataract extraction. The lens is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S004 S033 S013 S003 S022 S023 S017 S018 S019 S020 S021 
S028 S001 S031 S030 S015 S016 S029 S024 S025 S006 S007 S008 
S009 S010 S011 S012 S026 S027 S014 S036 S037 S034 S035 S038 
S040 S041 S039 
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