BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2161120 · Received June 17, 2011

    Report

    Report Number
    2028159-2011-00687
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Report Date
    May 20, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED AND IN-HOUSE EVAL IS IN PROGRESS. 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

    A HEALTHCARE PROFESSIONAL REPORTED THAT BUBBLES WERE NOTED DURING SURGERY. ADD'L INFO RECEIVED FROM THE NURSE INDICATED DURING TWO SEPARATE PROCEDURES, BUBBLES WERE OBSERVED IN THE CASSETTE TUBING AND IN A PT'S EYE. BOTH CASES WERE COMPLETED FOLLOWING EXCHANGE OF THE CASSETTE. THERE WAS NO HARM OR INJURY TO THE PTS.

    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 TOTAL PLUS PAK