PMA P220030S001

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: S001
Product code: LPO
Decision date: 2024-10-22
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) Implementing a pre- and post-assembly weight verification for UNIFEYE and UNIPEXY Gas Delivery Systems; 2) Implementing weighing cradles for UNIFEYE and UNIPEXY Gas Delivery Systems; 3) Updating the fixture travel length for the UNIFEYE Gas Delivery System during the insertion of the mixture stop into the plunger body. A new calibrated distance gauge will be used to verify this travel length.

Current openFDA PMA Record#

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: S001
Product code: LPO
Generic name: Gases used within eye to place pressure on detached retina
Decision date: 2024-10-22
Decision code: OK30
Date received: 2024-09-27
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) Implementing a pre- and post-assembly weight verification for UNIFEYE and UNIPEXY Gas Delivery Systems; 2) Implementing weighing cradles for UNIFEYE and UNIPEXY Gas Delivery Systems; 3) Updating the fixture travel length for the UNIFEYE Gas Delivery System during the insertion of the mixture stop into the plunger body. A new calibrated distance gauge will be used to verify this travel length.