PMA P040020S081

Device: AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant: Alcon Research, Ltd.
PMA number: P040020
Supplement: S081
Product code: MFK
Decision date: 2018-10-04
Classification: Lens, Multifocal Intraocular
Generic name: Lens, multifocal intraocular
Approval order statement: Add an alternate supplier for a manufacturing material used to manufacture the AcrySof® Posterior Chamber Single Piece Intraocular Lenses and the AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses.

Current openFDA PMA Record#

Device: AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant: Alcon Research, Ltd.
PMA number: P040020
Supplement: S081
Product code: MFK
Generic name: Lens, multifocal intraocular
Decision date: 2018-10-04
Decision code: OK30
Date received: 2018-09-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add an alternate supplier for a manufacturing material used to manufacture the AcrySof® Posterior Chamber Single Piece Intraocular Lenses and the AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses.