BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1891029 · Received October 29, 2010

    Report

    Report Number
    2028159-2010-02063
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER (PHYSICIAN) REPORTED: LIQUID WAS LEAKING OUT OF THE CASSETTE MEMBRANE AND CAUSED A SYSTEM ERROR WHEN SWITCHING FROM PHACO TO IRRIGATION/ASPIRATION MODE. THE SYSTEM WORKED FINE AFTER REPLACING THE CASSETTE AND RESTARTING THE SYSTEM. THE PROCEDURE WAS COMPLETED AND THE PHYSICIAN STATED THE PT WAS NO IMPACTED. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR CONSTELLATION 1061185H

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION SURGICAL PAK