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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 PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Trifocal UV Absorbing IOL, Clareon PanOptix Trifocal Hydroph
Generic NameLens, multifocal intraocular
ApplicantAlcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP190018
Supplement NumberS009
Date Received12/14/2020
Decision Date03/15/2021
Product Codes MFK MJP 
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 to expand dioptric-power range to 6.0 D - 34.0 D for Clareon PanOptix Trifocal Hydrophobic IOL (CNWTT0), Clareon PanOptix Trifocal UV Absorbing IOL (CCWTT0), and Clareon PanOptix Trifocal Hydrophobic IOL models CNWTT3-CNWTT6, as well as approval for Clareon PanOptix Toric Trifocal Hydrophobic IOL with the AutonoMe Automated Preloaded Delivery Device (CNATT3-CNATT6).
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