BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1982759 · Received January 6, 2011

    Report

    Report Number
    2028159-2011-00007
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Report Date
    December 8, 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
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE INVESTIGATION IS IN PROGRESS. A SAMPLE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED BALANCED SALT SOLUTION (BSS) DID NOT DRAIN INTO THE DRAIN BAG AND EVENTUALLY BACKED UP INTO THE FLUIDICS MODULE. THERE WERE VISIBLE SIGNS OF BSS OBSERVED IN THE FLUIDICS MODULE. THERE WAS NO PT IMPACT REPORTED. 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