BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MK-2000, KERATOME AND/OR EC-5000 EXCIMER LASER

    MDR report key: 1294955 · Received January 26, 2009

    Report

    Report Number
    2936921-2009-00001
    Event Type
    Injury
    Date Received
    January 26, 2009
    Report Date
    January 26, 2009
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PRESENTED IN THE NEWS BROADCAST, NIDEK INC IS UNABLE TO DETERMINE THE ROOT CAUSE OF THIS INJURY. NIDEK HAS TRAINED THIS FACILITY ON THE PROPER USE OF BOTH THE EC-5000 AND THE MK-2000. NIDEK HAS EVEN RE-TRAINED THIS FACILITY ON THE PROPER USE OF THE NIDEK DEVICES. NIDEK HAS PROVIDED THIS FACILITY WITH ON-GOING GUIDANCE ON MAINTAINING THEIR DEVICES. NO FURTHER INFORMATION OF THE PATIENT INJURY IS AVAILABLE AND HAS NOT BEEN PRESENTED TO NIDEK. THERE IS NO CONFIRMATION OF THIS CLAIM AND NO CONFIRMATION OF WHICH DEVICES CAUSED THIS INJURY. IF FURTHER INFORMATION IS RECEIVED, NIDEK WILL SUBMIT A FOLLOW UP REPORT. ADDITIONAL MODEL #: EC-5000.

    Description of Event or Problem · 1

    PATIENT HAS ALLEGEDLY CLAIMED ON A PUBLIC BROADCAST NEWS REPORT THAT SHE WAS INJURED DURING A LASIK SURGERY PROCEDURE, WHICH RESULTED IN HER REQUIRING SUTURES ON HER RIGHT CORNEA AND KNOW HAS A CATARACT FORMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MK-2000, KERATOME AND/OR EC-5000 EXCIMER LASER MK-2000 AND/OR EC-5000 HNO NIDEK CO., LTD. MK-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention