PMA P930014S143

Device: AcrySof Posterior Chamber Intraocular Lens and Delivery Systems
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S143
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: AcrySof Posterior Chamber Intraocular Lens and Delivery Systems
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S143
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.