BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2944089 · Received February 1, 2013

    Report

    Report Number
    2028159-2013-00110
    Event Type
    Injury
    Date Received
    February 1, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REMOTELY ADVISED THE CUSTOMER TO CHANGE THE CASSETTE, AS THEY HAVE HAD PREVIOUS CASSETTE ISSUES. THE COMPANY REP THEN PERFORMED AN ONSITE EVAL OF THE SYSTEM AND FOUND IT IN USE ON "EMERGENCY LISTS." THE CUSTOMER WILL RE-USE THE SYSTEM AND NOTIFY THE COMPANY REP IF THE ISSUE PERSISTS IN THE FUTURE. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLACE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID INDICATE ONE ADDITIONAL SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A PROCEDURE, THE PT EXPERIENCED A "SOFT" EYE DUE TO A LOSS OF PRESSURE IN THE SYSTEM; THE INSERTION FLOW BECAME UNSTABLE AND FLUCTUATED. IT WAS REPORTED THAT THE PT EXPERIENCED HARM; ADDITIONAL INFO HAS BEEN REQUESTED REGARDING THE NATURE OF THE HARM, BUT NO ADDITIONAL INFO HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43941 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other