BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2043075 · Received March 25, 2011

    Report

    Report Number
    2028159-2011-00288
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM, CONFIRMED THE REPORTED EVENT, AND REPLACED THE SUPERVISOR ASSEMBLY, LASER CORE MODULE, AND TABLE-TOP ILLUMINATOR. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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

    A CUSTOMER REPORTED DURING A PROCEDURE, THE SYSTEM'S LASER FUNCTION WAS UNAVAILABLE. A STANDALONE LASER WAS USED IN CONJUNCTION WITH THE SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO PT HARM OR INJURY 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