BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 4240947 · Received November 5, 2014

    Report

    Report Number
    3003288808-2014-01620
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 7, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    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 SURGEON REPORTED THAT DURING LASIK SURGERY, THE SYS HAD UNSTABLE ENERGY LEVELS, WHICH HAD TO BE READJUSTED. POSTOPERATIVELY, THE PT PRESENTED WITH HYPERMETROPIA IN THE LEFT EYE AND REPORTED UNCLEAR VISION. IN A FOLLOW UP, THE SURGEON REPORTED THAT NO SURGICAL OR MEDICAL INTERVENTION WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709869 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYS LZS WAVELIGHT GMBH 8065990713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other DEXAMETHASONE| SYSTANE| OFTAQUIX