BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 2201965 · Received August 4, 2011

    Report

    Report Number
    1119279-2011-00144
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE AKREOS AO60 DIRECTIONS FOR USE (DFU), AI-28 INSERTER IS RECOMMENDED FOR USE WITH AKREOS AO60 MODEL LENSES. THE COMPLAINT INFO INDICATES THAT A VISCOJECT 1.8 INSERTER WAS USED IN THE EVENT. 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 REVIEW COULD NOT BE PERFORMED FOR THE INSERTER DEVICE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED NOTICING A TORN HAPTIC AFTER THE AO60G IOL WAS INSERTED INTO THE PT'S EYE. THE LENS WAS CUT IN HALF AND REMOVED. THE INCISION WAS ENLARGED TO REMOVE THE LENS. THE BACKUP LENS WAS IMPLANTED SUCCESSFULLY, AND SUTURES WERE USED TO CLOSE THE INCISION. THE PT'S PROGNOSIS IS VERY GOOD. PLEASE REFERENCE MDR# 1119279-2011-00143.

    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 65 YR Required Intervention AKREOS ADVANCED OPTICS ASPHERIC LENS