PMA P040020S075

Device: AcrySof IQ ReSTOR Posterior Chambers Intraocular Lenses
Applicant: Alcon Research, Ltd.
PMA number: P040020
Supplement: S075
Product code: MFK
Decision date: 2017-12-21
Classification: Lens, Multifocal Intraocular
Generic name: Lens, multifocal intraocular
Approval order statement: Implementation of an automated cleaning system for initial cleaning of the AcrySof Intraocular Lenses at the Alcon Ireland manufacturing site.

Current openFDA PMA Record#

Device: AcrySof IQ ReSTOR Posterior Chambers Intraocular Lenses
Applicant: Alcon Research, Ltd.
PMA number: P040020
Supplement: S075
Product code: MFK
Generic name: Lens, multifocal intraocular
Decision date: 2017-12-21
Decision code: OK30
Date received: 2017-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of an automated cleaning system for initial cleaning of the AcrySof Intraocular Lenses at the Alcon Ireland manufacturing site.