BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 4240987 · Received November 5, 2014

    Report

    Report Number
    3003288808-2014-01556
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 6, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON ACCEPTANCE CRITERIA. 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 THE BILATERAL CENTRAL ABLATION WAS LESS THAN EXPECTED AND WAS NOT REGULAR DURING A LASIK PROCEDURE. THE PT WAS NOT HAPPY WITH THE OUTCOME AND NOTED SEEING SHADOWS AND GLARE. THERE ARE TWO MED DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710069 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYS LZS WAVELIGHT GMBH 8065990713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other MICROKERATOME - DATE UNK