PMA P040020S103

Device: AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant: Alcon Research, Ltd.
PMA number: P040020
Supplement: S103
Product code: MFK
Decision date: 2022-05-18
Generic name: Lens, multifocal intraocular
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 IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant: Alcon Research, Ltd.
PMA number: P040020
Supplement: S103
Product code: MFK
Generic name: Lens, multifocal intraocular
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.