PMA P230012

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: S010
Product code: LPO
Decision date: 2026-02-17
Classification: Ophthalmic
Generic name: Gases used within eye to place pressure on detached retina
Approval order statement: Approval to implement the following manufacturing change to UNIFEYE and UNIPEXY Gas Delivery Systems: NP34E to NP34D adhesive coating change on Tyvek 1073B.

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: S010
Product code: LPO
Generic name: Gases used within eye to place pressure on detached retina
Decision date: 2026-02-17
Decision code: OK30
Date received: 2026-01-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to implement the following manufacturing change to UNIFEYE and UNIPEXY Gas Delivery Systems: NP34E to NP34D adhesive coating change on Tyvek 1073B.