BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1913741 · Received November 12, 2010

    Report

    Report Number
    2028159-2010-02223
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    October 15, 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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM. THERE WAS AN ACCUMULATION OF BSS FOUND. THIS MAY HAVE CONTRIBUTED TO THE FAILURE OF THE IRRIGATION SYSTEM ON THE FLUIDICS MODULE. THE FLUIDICS MODULE WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM MESSAGE DISPLAYED DURING SETUP. THE CASE WAS CANCELLED AND THE PT WENT HOME AFTER HAVING ALREADY REC'D ANESTHESIA. THERE WAS NO PT 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