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Anodyne Surgical

Psi/Eye-Ko, Inc. · Model CL5001 · UDI-DI 00840516142463

HNR

510(k) clearances

888

Adverse events

Recalls

281

Facilities

Description

Scleral Plug Cross-Action Forceps, half moon, angled 9mm, polished tip, 105mm, SS

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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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.