BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISTA INTRAOCULAR LENS

    MDR report key: 3830226 · Received May 1, 2014

    Report

    Report Number
    1119279-2014-00076
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS BEEN RETURNED TO B&L AND IS CURRENTLY UNDER EVALUATION. INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS INSERTED INTO THE PATIENT'S RIGHT EYE AND REMOVED DUE TO THE HAPTIC DAMAGE. THE INCISION WAS ENLARGED TO REMOVE THE LENS, ANOTHER MODEL LENS WAS IMPLANTED, AND A SUTURE WAS USED. PLEASE REFERENCE COMPLAINT # 1119279-2014-00077 FOR THE DELIVERY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261186 ENVISTA INTRAOCULAR LENS HQL BAUSCH & LOMB MX60 3445008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INJ100 INTRAOCULAR LENS FOLDER AND INJECTOR