BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRO OCULYZER

    MDR report key: 3109432 · Received May 1, 2013

    Report

    Report Number
    3003288808-2013-00209
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    MXK
    PMA / PMN Number
    K071183
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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 REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED IRREGULAR IMAGES AND MEASUREMENTS WITH SYSTEM USE. PER TECHNICAL SERVICE REPRESENTATIVE THE CUSTOMER USED ANOTHER SYSTEM TO OBTAIN A RELIABLE MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190866 ALLEGRO OCULYZER ANTERIOR EYE SEGMENT ANALYSIS SYSTEM MXK WAVELIGHT GMBH 8065990641 NA

    Patients

    Seq Age Sex Outcome Treatment
    1