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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® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantHoya Surgical Optics, Inc.
14768 Pipeline Ave.
Chino Hills, CA 91709
PMA NumberP080004
Supplement NumberS040
Date Received04/12/2021
Decision Date05/07/2021
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  
Removal of the ethylene oxide ink indicator on individual sterilization pouches of fully preloaded intraocular lens devices, and replacement with an ethylene oxide indicator sticker that will be attached to the sterilization tray during batch sterilization.
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