BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1761147 · Received July 15, 2010

    Report

    Report Number
    2028159-2010-01184
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE RETURNED FOR EVALUATION. 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "SYSTEM MESSAGES DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). A SURGEON REPORTED THAT MULTIPLE SYSTEM MESSAGES WERE DISPLAYED DURING A SURGERY. THE SYSTEM WAS REBOOTED CAUSING A DELAY OF 7-10 MINUTES. ADDITIONAL INFORMATION 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