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Ophthalmic surgical procedure kit, non-medicated, single-use

FCI S A S FCI 20 22 · Model DISPOSABLE VITRECTOMY SET · UDI-DI 03760087122176

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510(k) clearances

Adverse events

Recalls

Facilities

Description

A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any pharmaceuticals. This is a single-use device.

Recalls

Date	Firm	Reason
2025-12-16	Vortex Surgical Inc.	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination
2016-02-02	Volk Optical Inc	The firm discovered that the incorrect lot number was engraved on the product.
2015-02-27	Volk Optical Inc	Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.

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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.