BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2925359 · Received January 17, 2013

    Report

    Report Number
    3003288808-2013-00013
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    WAVELIGHT AG
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    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 CUSTOMER REPORTED THAT THE LASER STOPPED 35% OF THE WAY THROUGH A LASIK TREATMENT. THEY WERE ABLE TO RE-ENTER THE REMAINING TREATMENT AND COMPLETE THE LASER SURGERY. THERE WAS NO HARM TO THE PT, AND AT ONE DAY POST-OP, THE PT HAD EXCELLENT VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26045 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT AG 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK