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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantHoya Surgical Optics, Inc.
14768 Pipeline Ave.
Chino Hills, CA 91709
PMA NumberP080004
Supplement NumberS015
Date Received03/19/2014
Decision Date06/16/2014
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN OPTICAL DESIGN CURVATURE MODIFICATION TO THE ISERT® MODEL 251 TO ADD A CONTROLLED POSITIVE SPHERICAL ABERRATION TO THE OPTIC. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISERT® GEMETRIC MODEL 751 AND IS INDICATEDFOR IMPLANTATION AFTER EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION OF CATARACTS IN ADULTS. THIS LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
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