PMA P230012

Device: UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System
Applicant: Alcon Research, LLC
PMA number: P230012
Supplement: S012
Product code: LPO
Decision date: 2026-09-30
Classification: Ophthalmic
Generic name: Gases used within eye to place pressure on detached retina
Approval order statement: Approval of implementing the following manufacturing changes: 1) Alternate supplier for the UNIFEYE screen and pad printing operations; 2) Alternate ink and additive third-party supplier for the UNIFEYE printed components; 3) Alternate third-party supplier to perform the machining and passivating processes for the Valve Seat component.

Current openFDA PMA Record#

Device: UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System
Applicant: Alcon Research, LLC
PMA number: P230012
Supplement: S012
Product code: LPO
Generic name: Gases used within eye to place pressure on detached retina
Decision date: 2026-09-30
Decision code: OK30
Date received: 2026-08-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of implementing the following manufacturing changes: 1) Alternate supplier for the UNIFEYE screen and pad printing operations; 2) Alternate ink and additive third-party supplier for the UNIFEYE printed components; 3) Alternate third-party supplier to perform the machining and passivating processes for the Valve Seat component.