BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 4810552 · Received May 29, 2015

    Report

    Report Number
    1313525-2015-01554
    Event Type
    Injury
    Date Received
    May 29, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 13, 2015
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS RETURNED FOR EVAL. THERE IS VERY LITTLE DRIED SOLUTION VISIBLE IN THE LOADING DECK AND NONE IN THE TIP. VISUAL INSPECTION FOUND THE TIP BENT. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO THE DAMAGE. THE LOT NUMBER OF THE DELIVERY DEVICE WAS NOT PROVIDED, THEREFORE A DEVICE HISTORY REVIEW (DHR) COULD NOT BE CONDUCTED. A REVIEW OF NONCONFORMANCES WAS PERFORMED AND THERE WERE NONE THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT IS POSSIBLE THAT USER RELATED FACTORS (SUCH AS LOADING OR HANDLING TECHNIQUES) AND/OR PROCEDURAL FACTORS (SUCH AS LENS AND INSERTER INTERACTION) MIGHT HAVE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INSERTING THE LENS IN THE PATIENT'S RIGHT EYE, THE LENS "POPPED BACK OUT." THE INCISION WAS ENLARGED, NO SUTURES WERE REQUIRED AND A BACKUP LENS WAS IMPLANTED WITH NO ISSUES. THE PATIENT'S PROGNOSIS WAS REPORTED AS "GOOD" AND NO ADDITIONAL TREATMENT IS NEEDED. REFERENCE MDR# 1313525-2015-01553 FOR THE LENS USED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349901 EZ-28 DELIVERY SYSTEM FOLDERS AND INJECTORS, IOL MSS BAUSCH + LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other LI61AO SILICONE INTRAOCULAR LENS (B+L)