BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK EC-5000 EXCIMER LASER SYSTEM

    MDR report key: 3415449 · Received October 11, 2013

    Report

    Report Number
    3002807715-2013-00005
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    August 28, 2008
    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

    ADD'L INVESTIGATION BY NIDEK INC. CONCLUDES THAT "WE HAVE NO REPORTED DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THE REPORTED ADVERSE EVENT FROM (B)(6) 2008 UNTIL WE RECEIVED NOTIFICATION FROM FDA." "BASED ON THE INFO PRESENTED, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THIS INJURY," AND "IF FURTHER INFO IS REC'D, WE WILL SUBMIT A F/U." NIDEK CO., LTD. ASKED NIDEK INC. FOR ADD'L INVESTIGATION. SINCE NIDEK CO., LTD ALSO COULD NOT HAVE FURTHER INFO TO PERFORM ADD'L INVESTIGATION AS A MFR, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE INJURY. IF FURTHER INFO IS REC'D, WE WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, NIDEK IN REC'D A LETTER STATING MAUDE EVENT REPORT, MW5016701 RELATED TO EC-5000 EXCIMER LASER SYSTEM. THIS LETTER STATED A PT HAD LASIK (B)(6) 2008. THE PT IS COMPLAINING OF CENTRAL ISLAND AND VISUAL DISTURBANCES AFTER LASIK. NIDEK CO., LTD. PREPARED THE CUSTOMER COMPLAINT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522348 NIDEK EC-5000 EXCIMER LASER SYSTEM NONE LZS NIDEK CO., LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention