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Ophthalmic trocar

FCI S A S FCI 20 22 · Model RETILOCK® 23G NON VALVED SELF-RETAINING TROCAR · UDI-DI 03760087123876

NGY Prescription

510(k) clearances

361

Adverse events

Recalls

Facilities

Description

A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture the eye to provide access to the interior of the eye for ophthalmic surgery. It is assembled and used together with a compatible cannula, filling its lumen and providing the necessary sharp point, thereby facilitating the introduction of this assembly. The trocar is withdrawn after puncturing, providing a working channel into the interior of the eye. It is typically available for use with an ophthalmic cannulation set. This is a reusable device.

Recalls

Date	Firm	Reason
2025-08-05	Alcon Research LLC	Due to incomplete seals in the pouch which provide the sterile barrier.
2023-02-20	Mani, Inc. - Kiyohara Facility	A packaging defect may compromise the sterile barrier.
2020-10-27	Mani, Inc. - Kiyohara Facility	Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
2020-10-27	Mani, Inc. - Kiyohara Facility	Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
2015-08-11	Alcon Research, Ltd.	The product has potential to leak beyond their design specification.
2015-08-11	Alcon Research, Ltd.	The product has potential to leak beyond their design specification.
2015-08-11	Alcon Research, Ltd.	The product has potential to leak beyond their design specification.
2012-05-29	Alcon Research, LTD.	This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit b
2009-04-29	Alcon Laboratories, Inc	Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.
2009-04-29	Alcon Laboratories, Inc	Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.

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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.