BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKER/CHANG IOL CUTTER

    MDR report key: 3928351 · Received June 17, 2014

    Report

    Report Number
    3019924-2014-00019
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HNF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE DEVICE HAD NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE PACKER/CHANG IOL SCISSOR BROKE WHEN THE SURGEON ATTEMPTED TO CUT A TORIC LENS. 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
    353880 PACKER/CHANG IOL CUTTER OPHTHALMIC SCISSOR HNF MICROSURGICAL TECHNOLOGY, INC. DFH-0012 048573

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR