BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 4213057 · Received October 24, 2014

    Report

    Report Number
    3003288808-2014-01574
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 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
    RS
    Reporter Occupation
    NOT APPLICABLE

    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

    AN ENGINEER REPORTED THAT THE ENERGY LEVELS OF THE LASER WERE UNSTABLE. AS A RESULT, THERE WAS LOW PRECISION IN THE RETRACTIVE CORRECTION OF TWO UNIDENTIFIED PT. IN A FOLLOW UP, THE SURGEON INDICATED THAT INSTEAD OF ATTAINING EIGHTY PERCENT OF THE EXPECTED CORRECTION, ONLY FIFTY PERCENT OF THE CORRECTION WAS ACHIEVED. ADDITIONAL INFO WAS REQUESTED FROM THE SURGEON; HOWEVER, HE DID NOT PROVIDE ADDITIONAL DETAILS OR IDENTIFIERS ABOUT THE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680054 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other