BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISTA INTRAOCULAR LENS

    MDR report key: 3922172 · Received May 23, 2014

    Report

    Report Number
    1119279-2014-00095
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    April 24, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. 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 PT PRESENTED WITH TASS POST LENS IMPLANTATION. THIS EVENT IS ONE OF 3 CASES REPORTED FROM THE SAME FACILITY INVOLVING LENSES IMPLANTED ON THE SAME DAY. THE REPORTER INDICATED THAT ONE OF THE THREE PTS UNDERWENT CORNEAL TRANSPLANT, AND THE OTHER TWO PTS MAY NEED CORNEAL TRANSPLANT AS WELL. ADD'L INFO HAS BEEN REQUESTED BUT NO NEW INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309186 ENVISTA INTRAOCULAR LENS HQL; INTRAOCULAR LENS HQL BAUSCH & LOMB, INC. MX60 3233663

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR