PMA P930014S118

Device: AcrySof Posterior Chamber Single Piece Intraocular Lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S118
Product code: HQL
Decision date: 2018-12-14
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Reducing the frequency of monomer inhibitor removal in-process testing for the AcrySof Posterior Chamber Single Piece Intraocular Lens and the AcrySof ReSTOR Posterior Chamber Intraocular Lens manufactured at the Cork Ireland site.

Current openFDA PMA Record#

Device: AcrySof Posterior Chamber Single Piece Intraocular Lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S118
Product code: HQL
Generic name: intraocular lens
Decision date: 2018-12-14
Decision code: OK30
Date received: 2018-11-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Reducing the frequency of monomer inhibitor removal in-process testing for the AcrySof Posterior Chamber Single Piece Intraocular Lens and the AcrySof ReSTOR Posterior Chamber Intraocular Lens manufactured at the Cork Ireland site.