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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™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL)
Generic Nameintraocular lens
ApplicantAlcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP190018
Supplement NumberS046
Date Received11/10/2025
Decision Date05/15/2026
Product Codes HQL MJP POE 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for expanding the range for Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic IOLs in the lens case configuration to include 4.50 D (CNWET7/CCWET7), 5.25 D (CNWET8/CCWET8), and 6.0 D (CNWET9/CCWET9) cylindrical power models.
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