PMA P230012S009

Device: UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
Applicant: Alcon Research, LLC
PMA number: P230012
Supplement: S009
Product code: LPO
Decision date: 2026-01-08
Classification: Ophthalmic
Generic name: Gases used within eye to place pressure on detached retina
Approval order statement: Approval to implement the following manufacturing changes to UNIFEYE and UNIPEXY Gas Delivery Systems: 1) replacement of the existing welding system at Picocyl, the supplier responsible for producing the pico-cylinder component, and 2) design update to the fill head component of the ALL02 Gas Filling System.

Current openFDA PMA Record#

Device: UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
Applicant: Alcon Research, LLC
PMA number: P230012
Supplement: S009
Product code: LPO
Generic name: Gases used within eye to place pressure on detached retina
Decision date: 2026-01-08
Decision code: OK30
Date received: 2025-12-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to implement the following manufacturing changes to UNIFEYE and UNIPEXY Gas Delivery Systems: 1) replacement of the existing welding system at Picocyl, the supplier responsible for producing the pico-cylinder component, and 2) design update to the fill head component of the ALL02 Gas Filling System.