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Goniotome +I/A Handpiece

NEOMEDIX CORPORATION · Model 550052-11 · UDI-DI 00854028002177

HNN Prescription

510(k) clearances

7,553

Adverse events

155

Recalls

206

Facilities

Description

The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil-like instrument with a graspable white ABS plastic outer shell (~1.5 cm diameter and ~13 cm length), a stainless steel probe (protruding about 2.2 cm from the tip of the white outer shell and covered by a protective purge chamber), irrigation and aspiration tubing extruded from DEHP-free PVC (~15 cm length) terminated with polycarbonate luer connectors. The diameter of the probe insertable into the eye is ~1.1 mm. The tip of the probe features a pointed footplate tip and dual sharpened edges fabricated of stainless steel. The Handpiece is intended to be used in ophthalmic surgery to manually cut Trabecular Meshwork (TM) in adult and infantile patients. The Handpiece can be connected to a suitable ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration of balanced salt solution (BSS) while the procedure is being performed.

Recalls

Date	Firm	Reason
2026-04-23	SSC- Surgical Specialties Corporation	3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
2025-08-20	MicroSurgical Technology Inc	An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
2025-04-25	Tecfen Medical	Sterility assurance for Ophthalmic knives.
2025-04-25	Tecfen Medical	Sterility assurance for Ophthalmic knives.
2025-04-25	Tecfen Medical	Sterility assurance for Ophthalmic knives.
2025-04-25	Tecfen Medical	Sterility assurance for Ophthalmic knives.
2025-04-25	Tecfen Medical	Sterility assurance for Ophthalmic knives.
2025-04-25	Tecfen Medical	Sterility assurance for Ophthalmic knives.
2025-04-25	Tecfen Medical	Sterility assurance for Ophthalmic knives.
2024-07-15	Alcon Research LLC	Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

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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.