- Device
- UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery
- Applicant
- Alcon Research, LLC
- PMA number
- P220030
- Supplement
- S005
- Product code
- LPO
- Generic name
- Gases used within eye to place pressure on detached retina
- Decision date
- 2025-03-24
- Decision code
- OK30
- Date received
- 2025-03-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- 1. Add Arrow Finishing (Blaine, MN, USA), formerly known as Arrow Cryogenics, as an alternate passivation process supplier to Picocyl LLC for the pico-cylinder cap, can, and spring subcomponents.2. Add three alternate fabrication suppliers: - J&J Machining (Elk River, MN, USA) for the pico-cylinder piston subcomponent - Stueken (Fountain Inn, SC, USA) for the pico-cylinder cap and can subcomponents - Western Spring Manufacturing (Hugo, MN, USA) for the pico-cylinder spring subcomponent