PMA P930014S138

Device: AcrySof Posterior Chamber Intraocular Lens
Applicant: Alcon Laboratories, Inc.
Product code: HQL
Decision date: 2022-10-28
Generic name: intraocular lens
Approval order statement: Approval for an updated analytical testing method for determination of Ethylene Oxide (EO) sterilant residuals and residual acetone on the subject devices by headspace gas chromatography.

Current openFDA PMA Record#

Device: AcrySof Posterior Chamber Intraocular Lens
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S138
Product code: HQL
Generic name: intraocular lens
Decision date: 2022-10-28
Decision code: APPR
Date received: 2021-07-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an updated analytical testing method for determination of Ethylene Oxide (EO) sterilant residuals and residual acetone on the subject devices by headspace gas chromatography.