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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.
 
DeviceCLARISERT PRELOADED IOL SYSTEM
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantHoya Surgical Optics, Inc.
14768 Pipeline Ave.
Chino Hills, CA 91709
PMA NumberP080004
Supplement NumberS016
Date Received12/28/2016
Decision Date03/31/2017
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 changes in the spherical aberration and thickness of the optic lens for your iSert® IOLs. You also requested approval for this lens to be distributed under a new private label under Bausch + Lomb Inc. as the ClarisertTM Preloaded IOL System (Model CLSRT).
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