BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK EC-5000 EXCIMER LASER SYSTEM

    MDR report key: 3415446 · Received October 11, 2013

    Report

    Report Number
    3002807715-2013-00002
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    June 15, 2004
    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 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 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 INC REC'D A LETTER STATING MAUDE EVENT REPORT RELATED TO EC-5000. THIS LETTER STATED A PT UNDERWENT THE LASIK PROCEDURE IN 2004. THE PT DEVELOPED THE LASIK-RELATED COMPLICATION KNOWN AS ECTAGIA, IATROGENIC KERATOCONUS OR SECONDARY KERATOCONUS IN 2008. ACCORDING TO THE INFO, THIS PT REQUIRED AN INTERVENTION DUE TO SIGNIFICANT NEGATIVE IMPACT ON THE VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522347 NIDEK EC-5000 EXCIMER LASER SYSTEM NONE LZS NIDEK CO., LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention