BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISTA INTRAOCULAR LENS

    MDR report key: 3851348 · Received May 22, 2014

    Report

    Report Number
    1119279-2014-00092
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    March 4, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 LENS WAS REMOVED INTRAOPERATIVELY FROM THE PATIENT'S EYE DUE TO A DIVOT NOTED IN THE IOL DURING INSERTION. ANOTHER LENS WAS IMPLANTED AND SUTURES WERE USED TO CLOSE THE WOUND. NO INFORMATION REGARDING THE INSERTER USED DURING THE PROCEDURE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305219 ENVISTA INTRAOCULAR LENS HQL/INTRAOCULAR LENS HQL BAUSCH + LOMB MX60US 3442302

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other