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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 and Clareon Toric Intraocular Lenses (IOLs)
Generic Nameintraocular lens
ApplicantAlcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP190018
Supplement NumberS001
Date Received04/16/2020
Decision Date07/15/2020
Product Codes HQL MJP 
Advisory Committee Ophthalmic
Clinical TrialsNCT03170154
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for 3 changes related to the shelf life of the Clareon IOLs: 1) 3 year shelf life labeling for the Clareon and Clareon Toric IOLs presented in the AutonoMe Pre-Loaded Delivery System (Models CNAOTO and CNAOT3-CNAOT9); 2) a revision of the labeled storage condition to 15-30 °C for the Clareon and Clareon Toric IOLs presented in the AutonoMe Pre-Loaded Delivery System (Models CNAOTO and CNAOT3-CNAOT9); and 3) a revision to the ongoing real-time shelf life study protocols to streamline planned testing.
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