BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 2783364 · Received October 1, 2012

    Report

    Report Number
    1119279-2012-00229
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MEDICEL AG
    Product Code
    HQL
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS REQUESTED, BUT HAS NOT BEEN RETURNED TO B+L FOR EVALUATION. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAPTIC WAS TORN AWAY FROM THE OPTIC DURING IMPLANTATION OF A MI60L INTRAOCULAR LENS. THE SURGEON REMOVED THE LENS AND ANOTHER MI60L INTRAOCULAR LENS WAS SUCCESSFULLY IMPLANTED THE PT'S LEFT EYE. THE PT PRESENTED FOR FOLLOW-UP TWO WEEKS AFTER SURGERY AND WAS DIAGNOSED WITH ENDOPHTHALMITIS. THE PT WAS SENT TO RETINA SPECIALIST FOR FURTHER TREATMENT. A VITRECTOMY WAS PERFORMED AND LABORATORY TESTS WERE POSITIVE FOR CANDIDA. THE PT WAS ALSO GIVEN INTRAOCULAR INJECTIONS. THE SURGEON DOES NOT KNOW WHAT WAS THE ORIGIN OF THE INFECTION. LENS REMAINS IMPLANTED. PLEASE REFERENCE MDR#: 1119279-2012-00228 FOR THE FIRST INTRAOCULAR LENS USED IN THIS CASE. PLEASE REFERENCE MDR#: 1119279-2012-00230 FOR THE SECOND INTRAOCULAR LENS USED IN THIS CASE. PLEASE REFERENCE MDR#: 1119279-2012-00231 FOR THE SECOND DELIVERY DEVICE USED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCOJECT 1.8 DELIVERY SYSTEM IOL INSERTER, INJECTOR HQL MEDICEL AG

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other AKREOS MICRO INCISION LENS (B+L)| VISCOJECT 1.8 DELIVERY SYSTEM (B+L)