BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q EXCIMER LASER

    MDR report key: 4850307 · Received June 17, 2015

    Report

    Report Number
    3003288808-2015-05678
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    December 2, 2014
    Report Date
    September 1, 2015
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM HISTORY SHOWS THAT THE LASER WAS VERIFIED SUCCESSFULLY PRIOR AND AFTER THE DATE OF TREATMENT. LOGFILES REVIEW SHOWS THAT THE CONCERNED TREATMENT WAS COMPLETED TO 100 % AND ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS AT THIS DAY. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. 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

    AN OPTOMETRIST REPORTED A PATIENT WITH CORNEAL EROSION OF THE LEFT EYE UPON WAKING 10 WEEKS POST LASIK TREATMENT. THE PATIENT REPORTED THE EYE DRYS OUT AND IS REQUIRED TO CONTINUALLY USE ARTIFICIAL TEARS. THE TOPICAL STEROIDS WERE INCREASED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394973 ALLEGRETTO WAVE EYE-Q EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention