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Ambler Surgical
AMBLER SURGICAL CORP. · Model Slit knife · UDI-DI 10190660200074
HNN
Prescription
10
510(k) clearances
7,502
Adverse events
155
Recalls
206
Facilities
Description
Slit knife, 2.5mm wide, angled NexGen blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6
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.