BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 2982508 · Received February 26, 2013

    Report

    Report Number
    3003288808-2013-00079
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 4, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P0
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING SURGERY, THE SYS DISPLAYED A MESSAGE AND LOCKED. WHEN THEY RESUMED THE TREATMENT, THE SYS DISPLAYED A MESSAGE INDICATING THAT 116% OF THE SHORTS WERE FINISHED. THE PT IS UNDERCORRECTED. THE PT WILL BE FOLLOWED AND ADD'L LASER TREATMENT MAY BE REQUIRED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81657 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other