PMA P190018S019

Device: Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S019
Product code: HQL
Decision date: 2022-05-03
Generic name: intraocular lens
Approval order statement: Transfer of the nozzle coating process during manufacturing of the AutonoMe Automated Pre-loaded Delivery System from Alcon Huntington, West Virginia to Alcon Laboratories, Ireland.

Current openFDA PMA Record#

Device: Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S019
Product code: HQL
Generic name: intraocular lens
Decision date: 2022-05-03
Decision code: OK30
Date received: 2022-04-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Transfer of the nozzle coating process during manufacturing of the AutonoMe Automated Pre-loaded Delivery System from Alcon Huntington, West Virginia to Alcon Laboratories, Ireland.