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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 TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL); Clareon TruPlus Toric Aspheric Hydrophobic Acrylic
Generic Nameintraocular lens
ApplicantAlcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP190018
Supplement NumberS047
Date Received11/21/2025
Decision Date02/19/2026
Product Codes MJP HQL 
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  
Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon TruPlus Toric Aspheric Hydrophobic Acrylic IOL, Clareon TruPlus Aspheric UV Absorbing IOL, and Clareon TruPlus Toric Aspheric UV Absorbing IOL in both lens case and AutonoMe Pre-loaded Delivery System configurations
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