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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.
 
DeviceHoya iSert and Clarisert Intraocular Lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantHoya Surgical Optics, Inc.
14768 Pipeline Ave.
Chino Hills, CA 91709
PMA NumberP080004
Supplement NumberS021
Date Received01/05/2018
Decision Date02/01/2018
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Modifications to the Final Inspection Work Instruction for haptic scratches at the HOYA Surgical Optics manufacturing site located in Singapore for the HOYA iSert® and Clarisert Intraocular lens (IOLs).
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