Goniotome Handpiece
NEOMEDIX CORPORATION · Model 550052-15 · UDI-DI 00854028002184
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), and a stainless steel probe (protruding about 2.2 cm from the tip of the white outer shell and covered by a protective purge chamber). 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.
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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