BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISTA INTRAOCULAR LENS

    MDR report key: 2855653 · Received November 30, 2012

    Report

    Report Number
    1119279-2012-00296
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD WAS REVIEWED FOR THE LENS AND THERE WERE NO NONCONFORMITIES OR ANOMALIES RELATED TO THIS COMPLAINT. THE PRODUCT WAS DEEMED ACCEPTABLE FOR RELEASE. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. THE EVENT INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE LENS WAS INSERTED INTO THE CAPSULAR BAG THE LENS HAPTIC RIPPED DURING UNFOLDING. THE INCISION WAS ENLARGED TO REMOVE AND REPLACE THE LENS WITH ANOTHER LENS. A STITCH WAS PLACED IN THE INCISION. THE LENS THAT WAS USED DURING THIS EVENT IS REPORTED UNDER 111927-2012-00297.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENVISTA INTRAOCULAR LENS HQL; INTRAOCULAR LENS HQL BAUSCH + LOMB MX60 3218421

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCUJECT DELIVERY DEVICE