BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 2896452 · Received December 28, 2012

    Report

    Report Number
    1119279-2012-00341
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE HAS BEEN RETURNED TO BAUSCH + LOMB FOR EVAL. 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 INTRAOCULAR LENS TORE IN HALF DURING INSERTION DUE TO SPLITTING OF THE INJECTOR TIP. THE LENS WAS SUBSEQUENTLY REMOVED THROUGH AN ENLARGED INCISION. PLEASE REFERENCE MDR# 1119279-2012-00295 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCOJECT 1.8 DELIVERY SYSTEM MSS/IOL INSERTER/INJECTOR MSS MEDICEL AG LP604350 114903

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other AKREOS ADVANCED OPTICS ASPHERIC LENS