BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19G PACKER/CHANG IOL CUTTERS

    MDR report key: 2557087 · Received April 27, 2012

    Report

    Report Number
    3019924-2012-00011
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    March 28, 2012
    Report Date
    April 27, 2012
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HNF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE SCISSOR BLADE BROKE WHILE THE SURGEON WAS CUTTING AN IOL. THERE WAS NO IMPACT TO THE PT OR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 19G PACKER/CHANG IOL CUTTERS OPHTHALMIC SCISSORS HNF MICROSURGICAL TECHNOLOGY, INC. DFH-0012 040797

    Patients

    Seq Age Sex Outcome Treatment
    1 Other