BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGETIC 23G CHANDELIER INFUSION LIGHT

    MDR report key: 1953632 · Received January 4, 2011

    Report

    Report Number
    MW5018892
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 7, 2010
    Report Date
    January 3, 2011
    Manufacturer
    SYNERGETIC
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, PARS PLANA VITRECTOMY, THE DEVICE SYNERGETIC 23 GAUGE CHANDELIER INFUSION LIGHT, PENETRATED THE EYE. PRODUCED CATARACT TO HIS EYE. THE LIGHT OF THE CHANDELIER SHOULD NOT PENETRATE THE EYE. PT HAD TO HAVE ANOTHER SURGERY OR APHAKIC AT FIRST ONE. NOTE: TO TALK (LEFT MESSAGE TO SYNERGETIC). TALK TO THEM IN A MEETING THEY GOT CONCERNED BUT NEVER DID ANY FURTHER FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGETIC 23G CHANDELIER INFUSION LIGHT CHANDELIER INFUSION 23 GAUGE LIGHT GEI SYNERGETIC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability