BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK EC-500 EXCIMER LASER SYSTEM

    MDR report key: 3415448 · Received October 11, 2013

    Report

    Report Number
    3002807715-2013-00004
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    March 26, 2009
    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) 2009 UNTIL WE RECEIVE NOTIFICATION FROM FDA." "WE PROVIDED NECESSARY INFO AND TRAINING TO SURGICAL DOCTORS WHO USE THE EC-5000 TO PREVENT ADVERSE EVENTS." "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 (B)(4) ASKED NIDEK INC. FOR ADD'L INVESTIGATION. SINCE NIDEK (B)(4) 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)(4) 2010, NIDEK INC REC'D A LETTER STATING MAUDE EVENT REPORT, (B)(4) RELATED TO EC-5000 EXCIMER LASER SYSTEM. THIS LETTER STATED A PT HAD LASIK (B)(6) 2009. THE PT IS COMPLAINING OF DRY EYE SYNDROME AND NIGH VISION DISTURBANCES AFTER LASIK. SYMPTOMS OF DRY EYE SYNDROME DID NOT BECOME NOTICEABLE UNTIL 3 MONTHS. NIDEK (B)(4) PREPARED THE CUSTOMER COMPLAINT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521572 NIDEK EC-500 EXCIMER LASER SYSTEM NONE LZS NIDEK CO., LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention