BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2922045 · Received January 15, 2013

    Report

    Report Number
    2028159-2013-00024
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 17, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED AND AN IN HOUSE INVESTIGATION IS IN PROGRESS.(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE TIP OF THE PROBE BROKE DURING SURGERY. THE SURGEON REMOVED THE TIP FROM THE ANTERIOR CHAMBER AND COMPLETED THE PROCEDURE WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22351 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25+ GAUGE TOTAL PLUS PAK 5.0 CPM