BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALEGRETTO WAVE EYE-Q

    MDR report key: 3900058 · Received May 27, 2014

    Report

    Report Number
    3003288808-2014-00910
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT HAS BEEN PERFORMED AND THE 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

    A SURGEON REPORTED A SYSTEM MESSAGE INDICATING SECONDARY ENERGY WAS TOO LOW WAS DISPLAYED DURING A PHOTO REFRACTIVE KERATECTOMY PROCEDURE PERFORMED USING THE "NO TOUCH" METHOD. THE LASER STOPPED WORKING AT 20% OF THE DIOPTER CORRECTION PHASE OF THE PROCEDURE. THE SURGERY WAS NOT COMPLETED AND THE PATIENT'S EYE WAS COVERED WITH A CONTACT LENS. THE DIOPTER OF THE EYE WAS INCREASED 0.5D AND THE SURGEON INDICATED ANOTHER SURGERY WOULD BE PERFORMED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311981 ALEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other