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Ambler Surgical

AMBLER SURGICAL CORP. · Model Ernest-McDonald II IOL inserting forceps · UDI-DI 00190660052003

HNR Prescription
10
510(k) clearances
861
Adverse events
16
Recalls
279
Facilities

Description

Ernest-McDonald II IOL inserting forceps, angled 5.0mm extra low-profile jaws, cross-action tips, flat handle

Recalls

DateFirmReason
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCOphthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding
2026-03-25Katalyst Surgical, LLCField 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.