PMA P190018S021

Device: Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S021
Product code: HQL
Decision date: 2022-12-20
Generic name: intraocular lens
Approval order statement: Change from two fixtures to a single fixture used for lens cleaning, extraction, vacuum drying and plasma treatment processes.

Current openFDA PMA Record#

Device: Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S021
Product code: HQL
Generic name: intraocular lens
Decision date: 2022-12-20
Decision code: OK30
Date received: 2022-11-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change from two fixtures to a single fixture used for lens cleaning, extraction, vacuum drying and plasma treatment processes.