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UNIPURE & UNIFEYE

Alcon Laboratories, Inc. · Model 8065753066 · UDI-DI 00380657530663

LPO Prescription
0
510(k) clearances
504
Adverse events
1
Recalls
3
Facilities

Description

UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.

Recalls

DateFirmReason
2003-11-18Alcon Laboratories, IncThe firm initiated the recall on 11/18/2003 via letters to all consignees. The letter advises physicians to stop using any patient bracelets (blue color) that contain the word 'st

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.