BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX5000 EXCIMER LASER

    MDR report key: 4213059 · Received October 24, 2014

    Report

    Report Number
    3003288808-2014-01573
    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
    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 INFORMATION 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 REFRACTIVE CORRECTION OF ONE UNIDENTIFIED PATIENT. IN A FOLLOW UP, THE SURGEON INDICATED THAT INSTEAD OF ATTAINING NINETY PERCENT OF THE EXPECTED CORRECTION, ONLY THIRTY TO FORTY PERCENT OF THE CORRECTION WAS ACHIEVED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SURGEON; HOWEVER, HE DID NOT PROVIDE ADDITIONAL DETAILS OR IDENTIFIERS ABOUT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679552 WAVELIGHT EX5000 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other