BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKER/CHANG IOL CUTTER

    MDR report key: 3131542 · Received May 16, 2013

    Report

    Report Number
    3019924-2013-00022
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HNF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED CORRODED, RUSTY AND DAMAGED, AN INDICATION THAT THE DEVICE WAS NOT MAINTAINED PER THE INSTRUCTIONS FOR USE AND USED TO CUT HARD OBJECTS OR MATERIAL. THIS DEVICE IS INTENDED TO CUT SOFT, FOLDABLE LENSES.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE PACKER/CHANG IOL CUTTER BROKE IN THE PATIENT'S EYE WHILE CUTTING AN IOL. THE BROKEN PIECE WAS REMOVED WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218397 PACKER/CHANG IOL CUTTER OPHTHALMIC SCISSOR HNF MICROSURGICAL TECHNOLOGY, INC. DFH-0012 049298

    Patients

    Seq Age Sex Outcome Treatment
    1