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Rumex

RUMEX INTERNATIONAL CORP. · Model 6-10/6-056 · UDI-DI 00840159909072

HNN
10
510(k) clearances
7,502
Adverse events
155
Recalls
206
Facilities

Description

Alfonso Corneal Transplant Knife, Length 110 mm, Straight Titanium Handle

Recalls

DateFirmReason
2026-04-23SSC- Surgical Specialties Corporation3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
2025-08-20MicroSurgical Technology IncAn ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2024-07-15Alcon Research LLCAlcon 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.