BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 3042897 · Received March 5, 2013

    Report

    Report Number
    3003288808-2013-00089
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING A ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    SURGEON REPORTED TREATMENT WAS TAKING TOO LONG, AND DECIDED TO STOP BY RELEASING THE FOOT PEDAL. IT WAS ALSO NOTED THAT THE TREATMENT STARTED FROM 0%, INSTEAD OF THE EXPECTED 70% AS THIS TREATMENT WAS INTENDED TO COMPLETE THE REMAINING TREATMENT FROM A PRIOR ABORTED SURGERY. PT OUTCOME WAS NOTED TO BE 20/20, A DAY AFTER THIS REPORTED EVENT. NO FURTHER DETAILS WERE SHARED WITH REGARDS TO THE PT OUTCOME. THE EVENT INVOLVING THE PRIOR ABORTED SURGERY, FOR THIS CASE HAS BEEN REPORTED EARLIER IN A DIFFERENT MFR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94718 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1