BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4120918 · Received July 25, 2014

    Report

    Report Number
    3003288808-2014-01163
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 25, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY 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 INFORMATION BECOMES AVAILABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, THE TECHNICIAN WAS UNABLE TO PROVIDE PATIENT IDENTIFIERS AND FURTHER INFORMATION. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT DURING LASIK SURGERY, THE LASER SYSTEM STOPPED TRACKING THE PUPIL DURING TREATMENT, AND SAID THE TREATMENT WAS COMPLETE, AND THEN IT SAID IT WAS NOT COMPLETE YET. THE SURGEON HAD TO RE-LIFT THE FLAP, AS HE HAD ALREADY PLACED IT BACK ON, IN ORDER TO COMPLETE THE TREATMENT. THE TECHNICIAN CONFIRMED THERE WAS NO PATIENT IMPACT NOTED THE DAY OF SURGERY. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436871 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1