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Rumex
RUMEX INTERNATIONAL CORP. · Model 6-20/6SK-075 · UDI-DI 00840159901908
10
510(k) clearances
7,502
Adverse events
155
Recalls
206
Facilities
Description
Phaco Sapphire Knife, Clear Cornea Blade, 2.20 mm, Length 135 mm, Angled 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.