|
Device | Clareon and Clareon Toric Intraocular Lenses (IOLs) |
Generic Name | intraocular lens |
Applicant | Alcon Laboratories, LLC 6201 South Freeway Fort Worth, TX 76134 |
PMA Number | P190018 |
Supplement Number | S001 |
Date Received | 04/16/2020 |
Decision Date | 07/15/2020 |
Product Codes |
HQL MJP |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT03170154
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |