PMA P040020S111

Device: AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant: Alcon Research, Ltd.
PMA number: P040020
Supplement: S111
Product code: MFK
Decision date: 2025-06-18
Classification: Ophthalmic
Generic name: Lens, multifocal intraocular
Approval order statement: approval for a manufacturing site located at [Alcon Huntington West Virginia, 2 Vision Lane, Lesage, West Virginia 25537 for manufacturing processes starting with injection molding and progressing through primary packaging and seal integrity testing.

Current openFDA PMA Record#

Device: AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant: Alcon Research, Ltd.
PMA number: P040020
Supplement: S111
Product code: MFK
Generic name: Lens, multifocal intraocular
Decision date: 2025-06-18
Decision code: APPR
Date received: 2024-12-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at [Alcon Huntington West Virginia, 2 Vision Lane, Lesage, West Virginia 25537 for manufacturing processes starting with injection molding and progressing through primary packaging and seal integrity testing.