BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q EXCIMER LASER

    MDR report key: 4943206 · Received July 27, 2015

    Report

    Report Number
    3003288808-2015-06037
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    July 2, 2015
    Report Date
    August 25, 2015
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON ACCEPTANCE CRITERIA. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PATIENT PRESENTED WITH A SCRATCHY FEELING IN THE RIGHT EYE ONE DAY POST LASIK. THE PATIENT WAS NOTED TO HAVE DIFFUSE LAMELLAR KERATITIS (DLK) IN THE RIGHT EYE. THE PREVIOUSLY PRESCRIBED TOPICAL STEROID EYE DROPS WERE INCREASED. ADDITIONAL INFORMATION PROVIDED STATES THAT THE PATIENT HAS NOT BEEN SEEN IN FOLLOW UP BUT IS EXPECTED TO FOLLOW UP AT A LATER DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED STATES THAT THE PATIENT WAS SEEN IN FOLLOW UP AND NOTED NO ISSUES. THE PATIENT IS CURRENTLY OFF ALL DROPS AND THE DLK HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487026 ALLEGRETTO WAVE EYE-Q EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention