BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2201130 · Received July 29, 2011

    Report

    Report Number
    2028159-2011-00874
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 2, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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 ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED SYSTEM MESSAGES WERE RECEIVED AND THE FRAGMENTATION HANDPIECE WOULD NOT PRIME DURING A PROCEDURE. THE SURGEON HAD ALREADY MADE AN INCISION TO RETRIEVE A LENS THAT HAD FALLEN POSTERIORLY DURING A PREVIOUS SURGERY. AFTER REPLACING THE CASSETTE FOR THE THIRD TIME, THE SYSTEM AND HANDPIECE PRIMED AND THE PROCEDURE WAS COMPLETED. THERE WAS A 30 MINUTE DELAY REPORTED. THERE WAS NO PT HARM OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1