BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISTA INTRAOCULAR LENS

    MDR report key: 4702001 · Received April 15, 2015

    Report

    Report Number
    1313525-2015-00780
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Report Date
    March 20, 2015
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOT SALINE SOLUTION IN THE LENS VIAL AND THE LENS WAS HARD AND IT COULD NOT BE FOLDED IN THE INJECTOR. WHITE CRYSTALS WERE FOUND STICKING TO THE LENS. THE LENS WAS NOT USED. THIS ISSUE OCCURRED WITH 10 LENSES. THIS REPORT REFERENCE LENS 6 OF 10. REF MDR# 1313525-2015-00773 FOR LENS 1 OF 10; -00774 FOR LENS 2 OF 10; -00775 FOR LENS 3 OF 10; -00776 FOR LENS 4 OF 10; -00777 FOR LENS 5 OF 10; -00778 FOR LENS 6 OF 10; -00779 FOR LENS 7 OF 10; -00781 FOR LENS 9 OF 10; -00782 FOR LENS 10 OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252549 ENVISTA INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB MX60A 3361303

    Patients

    Seq Age Sex Outcome Treatment
    1