BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISTA INTRAOCULAR LENS

    MDR report key: 4942139 · Received July 23, 2015

    Report

    Report Number
    1313525-2015-02155
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Report Date
    July 14, 2015
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE LENS AND LENS VIAL WERE NOT RETURNED TO THE B+L EVALUATION SITE; THEREFORE, PRODUCT EVALUATION COULD NOT BE CONDUCTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. BASED ON THE INFORMATION CURRENTLY AVAILABLE THE MOST LIKELY ROOT CAUSE OF THE EVENT IS RELATED TO A LEAKING LENS VIAL. THE TYPE OF LENS VIAL ASSOCIATED WITH THIS REPORT HAS BEEN DISCONTINUED AND A NEW (REDESIGNED) VIAL WAS IMPLEMENTED.

    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 THE LENS VIAL WAS FOUND DRY. THERE WAS NO LIQUID IN THE VIAL. THE LENS WAS NOT USED. THIS ISSUE OCCURRED WITH 2 LENSES. THIS REPORT REFERENCES LENS 2 OF 2. REF MDR# 131525-2015-02154 FOR LENS 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479098 ENVISTA INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB INCORPORATED MX60A 3224428

    Patients

    Seq Age Sex Outcome Treatment
    1