BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRO OCULYZER

    MDR report key: 9473665 · Received December 16, 2019

    Report

    Report Number
    3003288808-2019-01236
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    October 31, 2019
    Report Date
    December 16, 2019
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    MXK
    PMA / PMN Number
    K071183
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON ACCEPTANCE CRITERIA. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE VALUES OF CORNEA FRONT AND CORNEA BACK ARE NOT CORRECT DURING TESTING. THE MEASURED VALUE IS INACCURATE, NO SURGERY WAS PERFORMED. THE PROVIDED MEASUREMENTS WERE PREOPERATIVE MEASUREMENTS. THERE ARE TWO RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT FH, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR PATIENT FX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271790 ALLEGRO OCULYZER DEVICE, ANALYSIS, ANTERIOR SEGMENT MXK WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR