BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISTA INTRAOCULAR LENS

    MDR report key: 5140711 · Received October 9, 2015

    Report

    Report Number
    0001313525-2015-02784
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Report Date
    September 17, 2015
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS VIAL WAS FOUND TO HAVE LITTLE OR NO SALINE SOLUTION. THIS WAS DISCOVERED UPON RECEIPT AND THE PRODUCT WAS NOT USED. THIS REPORT REFERENCES LENS 7 OF 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671716 ENVISTA INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB INCORPORATED MX60A2350 3467553

    Patients

    Seq Age Sex Outcome Treatment
    1