BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRO OCULYZER

    MDR report key: 10570046 · Received September 22, 2020

    Report

    Report Number
    3003288808-2020-00548
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    August 12, 2020
    Report Date
    December 11, 2020
    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 · 0

    A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED SERIAL NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED CONFUSION WITH THE IMAGING DATA. THE DATA MEASURED WITH THE DEVICE WAS INCORRECT. ADDITIONAL INFORMATION AS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035659 ALLEGRO OCULYZER DEVICE, ANALYSIS, ANTERIOR SEGMENT MXK WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1