BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKER/CHANG IOL CUTTER

    MDR report key: 3899031 · Received May 20, 2014

    Report

    Report Number
    3019924-2014-00017
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HNF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCISSOR WAS RETURNED ALONG WITH THE ONE PIECE HARD IOL (UNCUT) WITH DAMAGE THAT IS INDICATIVE OF THE SCISSOR BEING USED TO CUT TOO HARD OF AN OBJECT. THE ONE PIECE LENS WAS SCORED WHERE THE SURGEON ATTEMPTED TO CUT THE LENS. THE SURGEON REPORTED THAT HE WAS ATTEMPTING TO USE THE SCISSOR TO CUT THE ONE PIECE ACRYLIC IOL. THIS SCISSOR IS INDICATED TO CUT SOFT FOLDABLE IOLS.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE PACKER/CHANG IOL SCISSOR BROKE WHEN THE SURGEON ATTEMPTED TO CUT A ONE 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
    299556 PACKER/CHANG IOL CUTTER OPHTHALMIC SCISSOR HNF MICROSURGICAL TECHNOLOGY, INC. DFH-0012 050336

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR