BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3915522 · Received June 4, 2014

    Report

    Report Number
    2028159-2014-01032
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A SURGERY THERE WAS A SUDDEN DROP IN EYE PRESSURE (POSTERIOR PORTION) FOR ABOUT FIVE SECONDS. THE INTRAOCULAR PRESSURE (IOP) CONTROL WAS ON AND ALL THE ENTRANCES TO THEIR CORRECT LOCATION AND CONNECTION WERE CHECKED. THE SURGEON DID NOT KNOW THE ROOT CAUSE OF THE EVENT. THE PT DID NOT EXPERIENCE ANY HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326135 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTALPLUS, 23G 5.0CPM VALVED STE