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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 (IOL)
Generic NameExtended depth of focus intraocular lens
Regulation Number886.3600
ApplicantAcu Focus, Inc.
32 Discovery Suite 200
Irvine, CA 92618
PMA NumberP210005
Supplement NumberS011
Date Received07/21/2025
Decision Date08/04/2025
Product Code POE 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a change to the address block of your labeling for the IC-8 Apthera IOL to align with other IOLs in the Bausch & Lomb portfolio
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