PMA P190018S020

Device: Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
Applicant: Alcon Laboratories, LLC
PMA number: P190018
Supplement: S020
Product code: HQL
Decision date: 2022-05-18
Generic name: intraocular lens
Approval order statement: Introduction of an additional sterilization chamber for routine sterilization of the subject devices using a new sterilization cycle at existing, approved sterilization service provider, Steris - AST Tullamore Ireland.

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: S020
Product code: HQL
Generic name: intraocular lens
Decision date: 2022-05-18
Decision code: OK30
Date received: 2022-04-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Introduction of an additional sterilization chamber for routine sterilization of the subject devices using a new sterilization cycle at existing, approved sterilization service provider, Steris - AST Tullamore Ireland.