BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1982743 · Received January 6, 2011

    Report

    Report Number
    2028159-2011-00006
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Report Date
    December 7, 2010
    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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE INVESTIGATION IS IN PROGRESS. A SAMPLE IS EXPECTED, BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A SYSTEM MESSAGE AND HAVING A LEAKY CASSETTE. THE CUSTOMER INDICATED THERE WAS NO PT INVOLVEMENT. ADDITIONAL INFO HAS BEEN REQUESTED.

    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