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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.
 
DeviceIC-8 Apthera Intraocular Lens
Generic NameExtended depth of focus intraocular lens
Regulation Number886.3600
ApplicantAcu Focus, Inc.
32 Discovery Suite 200
Irvine, CA 92618
PMA NumberP210005
Supplement NumberS005
Date Received06/01/2023
Decision Date07/31/2023
Product Code POE 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Bausch & Lomb, 21 N. Park Place Blvd., Clearwater, Florida, 33759 for the following functions: 1) Receiving inspections of device raw materials/ subassemblies 2) Shipping and handling of device raw materials/subassemblies 3) Lot release and documentation review of finished devices 4) Handling, storage, preservation and distribution of finished devices.
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