BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2120275 · Received June 7, 2011

    Report

    Report Number
    3003288808-2011-00110
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 8, 2011
    Report Date
    May 8, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A LASER TECHNICIAN REPORTS A SECONDARY ENERGY LOW MESSAGE DURING SURGERY. THE PROCEDURE WAS EXITED AND REPROGRAMMED AND THEN REENTERED. THE PROCEDURE WAS NOTED TO BE COMPLETED. ON FOLLOW-UP, THE TECHNICIAN STATED THIS CASE WILL UNDERGO AN ENHANCEMENT AFTER WHICH THE SURGEON WILL PROVIDE PATIENT INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention