BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3221879 · Received July 9, 2013

    Report

    Report Number
    2028159-2013-01359
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 11, 2013
    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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. ONE COMPONENT LOT NUMBER, MANUFACTURED IN FEBRUARY 2011, WAS IDENTIFIED WITH THIS COMPLAINT. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER COMPLAINT ISSUE WERE FOUND DURING THE REVIEW. THE PRODUCT WAS RELEASED ACCORDING TO THE MANUFACTURER'S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY REVIEW WAS PERFORMED WHICH INDICATES NO ADDITIONAL COMPLAINTS WERE ASSOCIATED WITH THE LOT. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE FIBER OPTIC ILLUMINATOR HAD AN EXCESSIVELY HOT TIP DURING A PROCEDURE. THEY CHANGED OUT THE ILLUMINATOR TWICE, AS THE SECOND ONE ALSO GOT HOT. THERE WAS NO SIGNIFICANT SURGICAL DELAY, AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312918 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 BULLET SHIELDED WIDE ANG ENDO