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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.
 
DeviceClareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens,
Generic Nameintraocular lens
ApplicantAlcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP190018
Supplement NumberS043
Date Received07/28/2025
Decision Date08/25/2025
Product Codes HQL MJP 
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  
the expansion of a clean room for manufacturing for the toric and non-toric Acrysof and Clareon IOLs
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