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General-purpose ophthalmic hook, reusable

FCI S A S FCI 20 22 · Model RITLENG HOOK · UDI-DI 03760087126259

HNQ Prescription

510(k) clearances

109

Adverse events

Recalls

187

Facilities

Description

A hand-held manual surgical instrument intended to facilitate the manipulation of ocular structures or to remove foreign bodies in the eye. It is typically shaft-like with a small curve (blunt- or pointed-end) or bend distally, and a handle proximally. The device is commonly used to retract eye muscles or to stabilize and manoeuver tissue during posterior segment surgery. This is a reusable 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
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
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2022-03-16	Carl Zeiss Meditec AG	High friction of the slider can cause the device to stick, or not move as intended.

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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.