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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 UV Absorbing Hydrophobic Intraocular Lens (IOL), Clareon PanOptix Toric Trifocal Hydrophobic I
Generic Nameintraocular lens
ApplicantAlcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP190018
Supplement NumberS012
Date Received08/26/2021
Decision Date02/14/2022
Product Codes HQL MJP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for additional manufacturing sites at Alcon Research, LLC (AODC-South) located at 6065 Kyle Lane Huntington, West Virginia and Alcon Research, LLC (AODC-North) located at 2 Vision Lane Lesage, West Virginia. The AODC-South facility performs the Injection Moulding through the Cosmetic Inspection manufacturing steps and the AODC-North facility performs the Pouching & Barseal through the Overwrap steps of the manufacturing process, as well as sterilization and distribution.
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