PMA P040020S110

Device: AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses
Applicant: Alcon Research, Ltd.
PMA number: P040020
Supplement: S110
Product code: MFK
Decision date: 2024-08-09
Classification: Ophthalmic
Generic name: Lens, multifocal intraocular
Approval order statement: expansion of ISO 7 class clean room space in existing facility used for manufacturing AcrySof®, AcrySof® IQ ReSTOR®, and Clareon Hydrophobic Intraocular Lenses

Current openFDA PMA Record#

Device: AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses
Applicant: Alcon Research, Ltd.
PMA number: P040020
Supplement: S110
Product code: MFK
Generic name: Lens, multifocal intraocular
Decision date: 2024-08-09
Decision code: OK30
Date received: 2024-07-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: expansion of ISO 7 class clean room space in existing facility used for manufacturing AcrySof®, AcrySof® IQ ReSTOR®, and Clareon Hydrophobic Intraocular Lenses