PMA P930014

Device: AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S144
Product code: HQL
Decision date: 2026-07-08
Generic name: intraocular lens
Approval order statement: the replacement of the existing external Process Challenge Device (ePCD) with two new ePCDs for microbiological assessment of process effectiveness during routine Ethylene Oxide (EO) sterilization of the subject devices

Current openFDA PMA Record#

Device: AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S164
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-07-08
Decision code: OK30
Date received: 2026-06-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the replacement of the existing external Process Challenge Device (ePCD) with two new ePCDs for microbiological assessment of process effectiveness during routine Ethylene Oxide (EO) sterilization of the subject devices