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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 Vivity™ Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity™ Toric Extended Vision Hydrophobic IO
Generic NameExtended depth of focus intraocular lens
ApplicantAlcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP190018
Supplement NumberS013
Date Received10/29/2021
Decision Date01/26/2022
Product Codes MJP POE 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Clareon Vivity Extended Vision Hydrophobic IOL and the Clareon Vivity Toric Extended Vision Hydrophobic IOL in lens case and AutonoMe Automated Pre-loaded Delivery System configurations.
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