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Rumex
RUMEX INTERNATIONAL CORP. · Model 6-00/6-020 · UDI-DI 00840159900734
10
510(k) clearances
7,553
Adverse events
155
Recalls
206
Facilities
Description
Diamond Knife For ICRS, Astigmatic And Arcuate Keratotomy, 1.00 mm Straight Blade, Length 110 mm, Micrometric Titanium Handle
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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Get your free API keyRead the docsData 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.