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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceUNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System
Generic NameGases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantAlcon Research, LLC
20511 Lake Forest Dr.
Lake Forest, CA 92630
PMA NumberP220030
Supplement NumberS012
Date Received08/31/2026
Decision Date09/30/2026
Product Code LPO 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of implementing the following manufacturing changes: 1) Alternate supplier for the UNIFEYE screen and pad printing operations; 2) Alternate ink and additive third-party supplier for the UNIFEYE printed components; 3) Alternate third-party supplier to perform the machining and passivating processes for the Valve Seat component.
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