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Titanium Irrigating Luer Handle

KATALYST SURGICAL LLC · Model 4011 · UDI-DI 00840096200218

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510(k) clearances

7,502

Adverse events

155

Recalls

206

Facilities

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.