BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 2051357 · Received April 7, 2011

    Report

    Report Number
    3003288808-2011-00055
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    SURGEON REPORTED TWO PTS WERE OVER-CORRECTED FOLLOWING REFRACTIVE SURGERY. SURGEON ALSO REPORTED SYSTEM FAILED ENERGY CHECKS BETWEEN PT CASES, WHICH OCCURRED AFTER COMPLETION OF TREATMENT ON THE TWO PTS WHO WERE REPORTED TO BE OVER-CORRECTED. PT OUTCOME DETAILS HAVE BEEN REQUESTED. THIS REPORT WILL REFERENCE THE SECOND PT. THE FIRST PT IS REPORTED UNDER MANUFACTURER REPORT # 3003288808-2011-00054.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other