BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRO OCULYZER

    MDR report key: 7578872 · Received June 7, 2018

    Report

    Report Number
    3003288808-2018-01086
    Event Type
    Injury
    Date Received
    June 7, 2018
    Date of Event
    May 15, 2018
    Report Date
    October 4, 2018
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    MXK
    PMA / PMN Number
    K071183
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 INFORMATION BECOMES AVAILABLE. MANUFACTURING RECORD REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER TEST MEASUREMENTS WITH TEST OBJECT, EXAMINATION SHOWED DATA GAPS RED AND BAD DETECTION. IF DATA GAPS SHOWS, THE MEASUREMENTS ARE INSUFFICIENT FOR USE BY THE LASER, THUS, NO PATIENT WILL BE AFFECTED. THE SAMPLE WAS FORWARDED TO SUPPLIER FOR REPAIR. THE SUPPLIER CLEANED THE COMPLETE OPTICS, REPLACED THE BOARD, THE SLIT PROJECTOR HOUSING, THE CAMERA ASSEMBLY, THE ALUMINUM DISC WITH THE LOOP TRACK AND STEEL INSERTS AND THE MOTOR BEARING. THE SUPPLIER ALSO PERFORMED ADJUSTMENT AND CALIBRATION OF THE SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY AS THE SUPPLIER DID NOT PROVIDE ANY DETAILS ABOUT ROOT CAUSE. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT MEASUREMENTS ARE NOT CORRECT. UPON FOLLOW UP, PROBLEM OCCURRED DURING MEASUREMENTS ON THE PATIENT PRIOR TO THE PROCEDURE. PROCEDURE WAS COMPLETED A FEW MINUTES LATER. PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422326 ALLEGRO OCULYZER DEVICE, ANALYSIS, ANTERIOR SEGMENT MXK WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other