BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE

    MDR report key: 4132805 · Received September 29, 2014

    Report

    Report Number
    3003288808-2014-01451
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION INCLUDING ROOT CAUSE IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON THE COMPANY'S ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEY HAD EYE TRACKER ISSUES DURING A LASIK PROCEDURE. THEY WERE UNABLE TO COMPLETE THE PROCEDURE, AND MAY COMPLETE IT AFTER THREE MONTHS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606250 ALLEGRETTO WAVE OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other