BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2192433 · Received July 27, 2011

    Report

    Report Number
    2028159-2011-00867
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED EVENTS. THE FLUIDICS MODULE WAS REPLACED. THE SYSTEM WAS THEN TESTED AND FOUND TO MEET ALL PRODUCT SPECIFICATIONS. THE FLUIDICS MODULE HAS BEEN RECEIVED AND TESTING IS IN PROGRESS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE 1 SIMILAR REPORT FOR THIS SYSTEM. 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 NURSE REPORTED THAT A PT WAS GIVEN GENERAL ANESTHESIA WITH THE INTENT OF HAVING LASER TREATMENT ON BOTH EYES. THE TREATMENT WAS COMPLETED ON THE FIRST EYE, BUT THEN DIFFICULTIES WITH THE RFID (RADIO FREQUENCY IDENTIFICATION) AND LIO (LASER INDIRECT OPHTHALMOSCOPE) REQUIRED THAT THE SYSTEM BE REBOOTED. BY THE TIME, THE PT WAS WAKING UP FROM THE ANESTHESIA. THE PROCEDURE ON THE SECOND EYE WAS CANCELLED AND THE PT WAS SENT HOME. THE PROCEDURE WILL BE COMPLETED WITHIN THE OFFICE DUE TO THE HIGH RISK NATURE OF THE PT.

    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 UNK Required Intervention