BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK EC-5000 EXCIMER LASER SYSTEM

    MDR report key: 3415464 · Received October 11, 2013

    Report

    Report Number
    3002807715-2013-00010
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    June 8, 1999
    Report Date
    October 10, 2013
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LZS
    PMA / PMN Number
    P970053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION BY NIDEK INC. CONCLUDES THAT "THE CONSULTANT CONTACTED BUT THE PT DID NOT HAVE ANY RESPONSE.", "SINCE THE DEVICE SPECIFICATIONS WERE ONLY FOR PRK, IT IS LIKELY THAT LASIK WAS PERFORMED WITH A MICROKERATOME OF OTHER COMPANIES.", AND "PERIODIC INSPECTION WAS CONDUCTED EVERY THREE MONTHS DURING THE TERM INCLUDING THE OCCURRENCE OF THE INCIDENT AND NO REPORT SUCH AS A MALFUNCTION HAD BEEN RECEIVED. THEREFORE, IT HAS BEEN CONFIRMED THAT THERE IS NO PROBLEM WITH QUALITY." 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) 2012. THE PT HAD LASIK EYE SURGERY AT A UNIVERSITY TO CORRECT THEIR ASTIGMATISM. THE INITIAL SURGERY DID NOT PRODUCE SATISFACTORY RESULTS THEREFORE A LASIK ENHANCEMENT WAS PERFORMED. WITHIN ONE YEAR OF BOTH LASIK AND LASIK ENHANCEMENT SURGERIES, THE PT WAS BACK TO WEARING CORRECTIVE LENSES. PT COMPLAINING OF VISION FADING OVER THE YEARS AND CORNEAL SCARRING. PT FEELS THEY HAVE NOT BENEFITTED FROM THEIR SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522618 NIDEK EC-5000 EXCIMER LASER SYSTEM NONE LZS NIDEK CO., LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention