BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 2201798 · Received August 5, 2011

    Report

    Report Number
    1119279-2011-00147
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DELIVERY DEVICE WAS NOT PROVIDED, AND THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. THEREFORE, A PRODUCT EVAL OR DEVICE HISTORY RECORDS (DHR) REVIEW COULD NOT BE PERFORMED. BASED ON THE INFO AVAILABLE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE SURGEON REPORTS THAT DURING THE INSERTION OF THE MI60LUS INTRAOCULAR LENS, THE PT'S CAPSULE WAS DAMAGED. THE LENS WAS REMOVED, AN ANTERIOR VITRECTOMY WAS PERFORMED, AND A DIFFERENT BAUSCH + LOMB MODEL WAS IMPLANTED. THE PT RECOVERED WELL. REFERENCE MDR #1119279-2011-00146 FOR THE INTRAOCULAR LENS USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCOJECT 1.8 DELIVERY SYSTEM IOL INSERTER/INJECTOR MSS BAUSCH & LOMB LP604350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AKREOS ADAPT AO MICRO INCISION LENS