BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAUSCH + LOMB IOL INJECTOR

    MDR report key: 3010472 · Received March 14, 2013

    Report

    Report Number
    1119279-2013-00070
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K113852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    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 THAT THE INTRAOCULAR LENS WAS REMOVED INTRAOPERATIVELY DUE TO THE TRAILING HAPTIC BEING TORN OFF IN THE DELIVERY DEVICE. THE INCISION WAS ENLARGED TO REMOVED THE LENS AND SUTURES WERE PLACED. ADD'L INFO HAS BEEN REQUESTED. PLEASE REFERENCE MDR#: 1119279-2013-00069 FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108205 BAUSCH + LOMB IOL INJECTOR MSS/INTRAOCULAR LENS FOLDER AND INJECTOR MSS BAUSCH & LOMB INJ100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ENVISTA ONE PIECE HYDROPHOBIC ACRYLIC IOL