PMA P930014S113

Device: AcrySof Posterior Chamber Single Piece Intraocular Lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S113
Product code: HQL
Decision date: 2018-10-04
Classification: Intraocular Lens
Generic name: intraocular lens
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 Posterior Chamber Single Piece Intraocular Lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S113
Product code: HQL
Generic name: intraocular lens
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.