BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4213045 · Received October 24, 2014

    Report

    Report Number
    3003288808-2014-01575
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    July 25, 2014
    Report Date
    September 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
    NOT APPLICABLE

    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 CENTER DIRECTOR REPORTED BILATERAL LIGHT SENSITIVITY, OBSERVED AT ONE MONTH POST PHOTO REFRACTIVE KERATECTOMY (PRK). REPORTER INDICATED THE TOPICAL STEROID EYE DROPS WERE INCREASED. UPON ADDITIONAL FOLLOW UP, REPORTER INDICATED THE PT ISSUE WAS RESOLVED. THERE ARE TWO RELATED REPORTS FOR THIS PT. THIS REPORT ADDRESSES THE PT'S RIGHT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678074 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention