BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 2792294 · Received October 12, 2012

    Report

    Report Number
    1119279-2012-00240
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    August 21, 2012
    Report Date
    September 12, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 AFTER THE LI61SE INTRAOCULAR LENS WAS INSERTED INTO THE PT'S EYE, THE SURGEON NOTICED THAT THE TRAILING HAPTIC WAS BENT. DURING THE REMOVAL OF THE LENS VITREOUS PROLAPSE OCCURRED AND AN ANTERIOR CHAMBER LENS WAS IMPLANTED SUCCESSFULLY. THE PT'S MOST RECENT BCDVA WAS REPORTED AS 20/40. THE PT'S PROGNOSIS IS GOOD. PLEASE REFERENCE MDR# 1119279-2012-00239 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ-28 DELIVERY SYSTEM IOL INSERTER/INJECTOR MSS BAUSCH + LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SOFPORT SQUARE EDGE LENS (B+L), LI61SE