BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACKER/CHANG IOL CUTTER

    MDR report key: 2634278 · Received June 25, 2012

    Report

    Report Number
    3019924-2012-00025
    Event Type
    Injury
    Date Received
    June 25, 2012
    Date of Event
    May 24, 2012
    Report Date
    June 25, 2012
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC.
    Product Code
    HNF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATING ROOM SUPERVISOR STATED THAT THEY WOULD NOT RETURN THE DEVICE UPON ADVICE FROM THEIR INSURANCE COMPANY. THE OPERATING ROOM SUPERVISOR PROVIDED 10 PHOTOGRAPHS (TELEPHONE CAMERA) OF THE DEVICE BUT THE MAGNIFICATION IS NOT SUFFICIENT TO MAKE DETERMINATIONS ABOUT THE PRODUCT.

    Description of Event or Problem · 1

    THE OPERATING ROOM SUPERVISOR FOR AN OPHTHALMIC SURGEON REPORTED A SERIOUS INJURY OCCURRED WHEN A SURGEON, USING A DFH-00012, PACKER/CHANG IO. CUTTER DURING AN OPHTHALMIC TRAUMA SURGERY, WAS CUTTING AN ACRYLIC IOL WHEN ONE OF TWO BLADES BROKE OFF-OF THE DEVICE. THE LOOSE BLADE FELL TO THE BACK OF THE EYE AND THE SURGERY WAS INTERRUPTED SO THE PT COULD IMMEDIATELY BE REFERRED TO A RETINAL SURGEON. THE RETINAL SURGEON WAS ABLE TO REMOVE THE LOOSE BLADE W/O INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACKER/CHANG IOL CUTTER OPHTHALMIC SCISSOR HNF MICROSURGICAL TECHNOLOGY INC. DFH-0012 045289

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention