BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4132807 · Received September 29, 2014

    Report

    Report Number
    3003288808-2014-01439
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    June 11, 2014
    Report Date
    September 16, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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

    A OPTOMETRIST REPORTED A PATIENT WITH LIGHT SENSITIVITY FOUR WEEKS POST (PRK) PHOTOREFRACTIVE KERATECTOMY ENHANCEMENT IN THE RIGHT EYE. THE STEROID DROP WAS INCREASED. THE REPORTED LIGHT SENSITIVITY HAS CLEARED, DROPS HAVE BEEN STOPPED AND THE VISION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606956 ALLEGRETTO WAVE EYE-Q OPTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention