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WATZKE FORCEPS
FCI S A S FCI 20 22 · Model S5.3100 · UDI-DI 13760087126294
HNR
Prescription
10
510(k) clearances
888
Adverse events
16
Recalls
280
Facilities
Description
A hand-held manual ophthalmic surgical instrument with small blades designed to grasp and manipulate ophthalmic implants (excluding sutures) during implantation/explantation; it is not intended for use on tissues. Its design may be tweezers-like, or it may be probe-like with a proximal handle, a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
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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.