BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKER/CHANG IOL CUTTER

    MDR report key: 3941040 · Received April 24, 2014

    Report

    Report Number
    3019924-2014-00013
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HNF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCISSOR WAS RETURNED DIRTY, CORRODED AND WITH DAMAGE THAT IS INDICATIVE OF THE SCISSOR BEING USED TO CUT TOO HARD AN OBJECT. THE SURGEON REPORTED THAT HE WAS ATTEMPTING TO USE THE SCISSOR TO CUT A THREE PIECE ACRYLIC IOL. THIS SCISSOR IS INDICATED TO CUT SOFT FOLDABLE IOLS.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE PACKER/CHANG IOL SCISSOR BROKE WHEN HE ATTEMPTED TO CUT A THREE PIECE ACRYLIC IOL. THERE WAS NO IMPACT TO THE PATIENT AND THE BROKEN PIECE WAS REMOVED FROM THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248511 PACKER/CHANG IOL CUTTER HNF MICROSURGICAL TECHNOLOGY, INC. DFH-0012 044854

    Patients

    Seq Age Sex Outcome Treatment
    1