BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 2.2 DELIVERY SYSTEM

    MDR report key: 3565315 · Received January 2, 2014

    Report

    Report Number
    2031924-2014-00002
    Event Type
    Injury
    Date Received
    January 2, 2014
    Date of Event
    August 13, 2013
    Report Date
    December 6, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PT PRESENTED WITH ENDOPHTHALMITIS ON POST-OP DAY 8. INTRAVITREAL INJECTION WAS GIVEN. THE SURGEON INDICATED THAT IN HIS OPINION THE LIKELY CAUSE OF THE EVENT WAS INTRA-OPERATIVE ENDOPHTHALMITIS. THE PT'S CURRENT PROGNOSIS IS DESCRIBED AS: VISION IS STABLE, UCVA: 20/30. THIS REPORT PERTAINS TO THE PT'S RIGHT EYE. REFERENCE MDR #2031924-2014-00001 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2581 VISCOJECT 2.2 DELIVERY SYSTEM MSS/IOL INSERTER/INJECTOR MSS MEDICEL AG VISCOJECT 2.2

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other CRYSTALENS ACCOMMODATING IOL