BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3772288 · Received December 19, 2013

    Report

    Report Number
    2028159-2013-02421
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    December 4, 2013
    Report Date
    December 4, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    A CUSTOMER REPORTED THAT THE SURGEON WAS "DAZZLED" WHEN ONE LASER SHOT WAS RELEASED DURING A PROCEDURE. ACCORDING TO THE HEAD NURSE, THE DOCTOR FILTER WAS OUT OF PLACE OR NOT CONNECTED WITH THE SYSTEM. THE DOCTOR INDICATED THAT THE LASER PROTECTION FILTER HAD NOT BEEN PUT IN PLACE AT THE TIME OF THE PROCEDURE. THERE WAS NO HARM TO THE DOCTOR OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667724 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1