BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3950912 · Received July 14, 2014

    Report

    Report Number
    3003288808-2014-01109
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED PATIENT WITH DIFFUSE WHITE BLOOD CELLS IN STROMA, BOTH WITHIN AREA OF EPITHELIAL DEFECT AND OUTSIDE EPITHELIAL DEFECT AT ONE DAY PHOTOREFRACTIVE KERATECTOMY (PRK) POST-OPERATIVE VISIT. AT VISIT PATIENT COMPLAINED OF EYES BEING "VERY UNCOMFORTABLE". ADDITIONAL INFORMATION FROM REPORTER INDICATED THE PATIENT'S TOPICAL STEROID DOSAGE WAS INCREASED AND ORAL STEROIDS WERE PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT REFERENCES THE LEFT EYE. AN ADDITIONAL REPORT WILL BE FILED FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410153 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention