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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.
 
DeviceANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAAREN SCIENTIFIC
4290 EAST BRICKELL ST, BLDG A
ONTARIO, CA 91761
PMA NumberP010027
Date Received04/30/2001
Decision Date11/21/2001
Withdrawal Date 08/20/2014
Product Code HQL 
Docket Number 02M-0180
Notice Date 05/07/2002
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ALLERGAN, INC. MODEL AC21B ULTRAVIOLET-ABSORBING PMMA ANTERIOR CHAMBER INTRAOCULAR LENS, AVAILABLE IN THREE OVERALL DIAMETERS (12.0 MM, 13.0 MM, 14.0 MM). THE APPLICATION IS A LICENSING PMA IN WHICH ALLERGAN, INC. HAS GIVING OPHTHALMIC INNOVATIONS INTERNATIONAL, INC. REFERENCE RIGHTS TO P860034. ADDITIONALLY, IT IS REQUESTED THAT ALLERGAN, INC. DISTRIBUTE THE LENS AS THE DURALENS II MODEL AC21B. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS IN THE VISUAL CORRECTION OF APHAKIA. THE ANTERIOR CHAMBER INTRAOCULAR LENS IS TO BE USED IN PATIENTS 60 YEARS OF AGE AND OLDER WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY PRIMARY INTRACAPSULAR CATARACT EXTRACTION (ICCE); OR BY PRIMARY EXTRACAPSULAR CATARACT EXTRACTION (ECCE) WHERE THERE IS A STRUCTURAL REASON THAT THE ANTERIOR CHAMBER LENS IS THE PREFERRED ONE; OR OTHER PRIMARY ECCE PROVIDED THAT THIS BE PERFORMED ONLY AFTER THE PHYSICIAN HAS COMPARED THE PUBLISHED RESULTS OF THE ANTERIOR CHAMBER LENS WITH POSTERIOR CHAMBER LENSES; OR IN A SECONDARY IMPLANT PROCEDURE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S002 S003 S004 S005 
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