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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 Pro Trifocal Intraocular Lens (IOL), Clareon PanOptix Pro Trifocal Toric IOLs, Clareon PanOptix Pro Tr
Generic Nameintraocular lens
ApplicantAlcon Laboratories, LLC
6201 S. Freeway
Fort Worth,, TX 76134
PMA NumberP190018
Supplement NumberS029
Date Received09/27/2023
Decision Date12/18/2023
Product Codes HQL 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 for the following Clareon PanOptix Pro models as a minor optical modification of the approved Clareon PanOptix models: Clareon PanOptix Pro Trifocal Intraocular Lens (IOL) Model PXYWT0, Clareon PanOptix Pro Trifocal Toric IOLs Models PXYWT3 – PXYWT6, Clareon PanOptix Pro Trifocal UV Absorbing IOL Model PXCWT0, Clareon PanOptix Pro Trifocal Toric UV Absorbing IOLs Models PXCWT3 – PXCWT6 , Clareon PanOptix Pro Trifocal IOL with the AutonoMe Automated Pre-loaded Delivery System Model PXYAT0, Clareon PanOptix Pro Trifocal Toric IOLs with the AutonoMe Automated Pre-loaded Delivery System Models PXYAT3 – PXYAT6, Clareon PanOptix Pro Trifocal UV Absorbing IOL with the AutonoMe Automated Pre-loaded Delivery System Model PXCAT0, Clareon PanOptix Pro Trifocal Toric UV Absorbing IOLs with the AutonoMe Automated Pre-loaded Delivery System Models PXCAT3 – PXCAT6
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