BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKER/CHANG IOL CUTTER

    MDR report key: 3983601 · Received June 25, 2014

    Report

    Report Number
    3019924-2014-00021
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HNF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCISSOR WAS RETURNED DIRTY AND CORRODED AT THE SITE OF THE BREAK INDICATING IT HAD NOT BE MAINTAINED ADEQUATELY PER THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE PACKER/CHANG IOL SCISSORS BROKEN WHEN THE SURGEON ATTEMPTED TO CUT A LENS. THE BROKEN PIECE OF THE SCISSOR FELL TO THE BACK OF THE EYE AND THE PATIENT WAS REFERRED TO A RETINAL SURGEON TO HAVE THE PIECE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372240 PACKER/CHANG IOL CUTTER OPHTHALMIC SCISSOR HNF MICROSURGICAL TECHNOLOGY, INC. DFH-0012 045234

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention