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Vitrectomy contact lens, single-use

FCI S A S FCI 20 22 · Model DISPOSABLE VITRECTOMY LENS · UDI-DI 03760087122183

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510(k) clearances

Adverse events

Recalls

Facilities

Description

A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. 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.