BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALEN

    MDR report key: 1991026 · Received February 11, 2011

    Report

    Report Number
    2031924-2011-00037
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    October 28, 2010
    Report Date
    January 19, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. THE LENS WAS RETURNED TO B+L AND SUBJECTED TO VISUAL INSPECTION. RESULTS REVEALED TWO TEARS ON THE EDGE OF THE LEADING HAPTIC PLATE AND A TEAR THROUGHOUT THE OPTIC. ALSO, PARTIAL PORTION OF THE OPTIC AND THE ENTIRE TRAILING HAPTIC PLATE WERE MISSING. DIMENSIONAL MEASUREMENTS COULD NOT BE PERFORMED DUE TO THE TORN CONDITION OF THE LENS. RETAIN SAMPLE NOT AVAILABLE TO VERIFY DIMENSIONAL MEASUREMENTS. THE CONDITION OF THE LENS IS CONSISTENT WITH THE LENS THAT WAS REMOVED FROM THE EYE. THE INSERTER DEVICE WAS NOT RETURNED. TORN HAPTIC PLATE/OPTIC, MISSING HAPTIC PLATE.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPT IMPLANTATION OF THE CRYSTALEN INTRAOCULAR LENS. INTRAOPERATIVELY, THE SURGEON NOTED A BROKEN HINGE. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE THE LENS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALEN INTRAOCULAR LENS NAA BAUSCH + LOMB AT50SE 009702

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention