Home › FCI S A S FCI 20 22 › Ophthalmic soft-tissue surgical forceps, probe-like, reusable

Ophthalmic soft-tissue surgical forceps, probe-like, reusable

FCI S A S FCI 20 22 · Model ENDONASAL FORCEPS · UDI-DI 03760087126242

HNR Prescription

510(k) clearances

904

Adverse events

Recalls

282

Facilities

Description

A hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.

Recalls

Date	Firm	Reason
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

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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.