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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, and Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Pre
Generic NameLens, multifocal intraocular
ApplicantAlcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP190018
Supplement NumberS002
Date Received04/21/2020
Decision Date07/20/2020
Product Codes HQL MFK 
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 PanOptix Trifocal Hydrophobic IOL Model CNWTT0 and the Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Preloaded Delivery System Model CNATT0.
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