BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK EC-5000 EXCIMER LASER SYSTEM

    MDR report key: 3415462 · Received October 11, 2013

    Report

    Report Number
    3002807715-2013-00008
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    January 18, 2005
    Report Date
    October 10, 2013
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION IS NOT POSSIBLE BECAUSE THERE IS ONLY INFORMATION ABOUT PT COMPLAINING OF NIGHT TIME GLARE. IN ADDITION, THE FACILITY OR SUCH IS NOT IDENTIFIED. NIDEK CO., LTD. ASKED NIDEK INC. FOR ADDITIONAL INVESTIGATION. SINCE NIDEK CO., LTD ALSO COULD NOT HAVE FURTHER INFORMATION TO PERFORM ADDITIONAL INVESTIGATION AS A MANUFACTURER, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE INJURY. IF FURTHER INFORMATION IS RECEIVED, WE WILL SUBMIT A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    NIDEK RECEIVED MAUDE EVENT REPORT (B)(4) (B)(6) 2011. PT COMPLAINING OF NIGHT TIME GLARE, STARBURSTS AND HALOS AROUND LIGHTS AFTER THEIR BILATERAL LASIK SURGERY IN 2005. PT IS UNABLE TO DRIVE AT NIGHT AND CANNOT SEE ROAD SIGNS OR PEOPLE. NIDEK CO., LTD. PREPARED THE CUSTOMER COMPLAINT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521573 NIDEK EC-5000 EXCIMER LASER SYSTEM NONE LZS NIDEK CO., LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention