PMA P230012S011

Device: UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System
Applicant: Alcon Research, LLC
PMA number: P230012
Supplement: S011
Product code: LPO
Decision date: 2026-05-28
Classification: Ophthalmic
Generic name: Gases used within eye to place pressure on detached retina
Approval order statement: addition of a UNIFEYE nose piece bonding fixture used on the UNIFEYE check valve subassembly during the bonding and curing processes, changing from a manual to an automated torque test fixture to verify the bonding; and updating to the torque test method used during the UNIFEYE final assembly process for torque testing of the UNIFEYE check valve and mixture stop subassemblies.

Current openFDA PMA Record#

Device: UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System
Applicant: Alcon Research, LLC
PMA number: P230012
Supplement: S011
Product code: LPO
Generic name: Gases used within eye to place pressure on detached retina
Decision date: 2026-05-28
Decision code: OK30
Date received: 2026-05-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of a UNIFEYE nose piece bonding fixture used on the UNIFEYE check valve subassembly during the bonding and curing processes, changing from a manual to an automated torque test fixture to verify the bonding; and updating to the torque test method used during the UNIFEYE final assembly process for torque testing of the UNIFEYE check valve and mixture stop subassemblies.