BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISTA IOL

    MDR report key: 4762717 · Received May 7, 2015

    Report

    Report Number
    1313525-2015-01411
    Event Type
    Malfunction
    Date Received
    May 7, 2015
    Report Date
    April 8, 2015
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE LENS AND LENS VIAL WERE NOT RETURNED FOR EVALUATION. THE LOT HISTORY RECORD WAS REVIEWED AND THERE WERE NO NON-CONFORMITIES OR ANOMALIES RELATED TO THIS COMPLAINT. 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 WAS DRY. THERE WAS NO LIQUID IN THE VIAL AND WHITE POWDER WAS PRESENT IN THE PACKAGING. THE LENS WAS NOT USED. THIS EVENT OCCURRED WITH SEVEN LENSES. THIS REPORT REFERS TO LENS 1 OF 9. REFERENCE MDR # 1313525-2015-01412, FOR LENS 2 OF 9; -01413 FOR LENS 3 OF 9; -01414 FOR LENS 4 OF 9; -01415 FOR LENS 5 OF 9; -01416 FOR LENS 5 OF 9; -01417 FOR LENS 7 OF 9; 01418 FOR LENS 8 OF 9; 01419 FOR LENS 9 OF 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300719 ENVISTA IOL LENS, INTRAOCULAR HQL BAUSCH & LOMB MX60 3223428

    Patients

    Seq Age Sex Outcome Treatment
    1