PMA P190018S001

Device: Clareon and Clareon Toric Intraocular Lenses (IOLs)
Applicant: Alcon Laboratories, LLC
Product code: HQL
Decision date: 2020-07-15
Generic name: intraocular lens
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.

Current openFDA PMA Record#

Device: Clareon and Clareon Toric Intraocular Lenses (IOLs)
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S001
Product code: HQL
Generic name: intraocular lens
Decision date: 2020-07-15
Decision code: APPR
Date received: 2020-04-16
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.