BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION

    MDR report key: 1983104 · Received February 4, 2011

    Report

    Report Number
    2028159-2011-00072
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING THE PROCEDURE, THE SYSTEM DISPLAYED AN ERROR MESSAGE, THE USER WAS UNABLE TO CLEAR THE MESSAGE. A BACKUP SYSTEM WAS BROUGHT IN AND THE SAME ERROR MESSAGE WAS DISPLAYED AS WELL. THE SURGEON WAS UNABLE TO COMPLETE THE PROCEDURE AS PLANNED. AN ALTERNATIVE PROCEDURE WAS PERFORMED. THE SURGEON IS UNSURE IF AN ADD'L PROCEDURE WILL BE REQUIRED. ADD'L F/U INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1