BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2031374 · Received March 23, 2011

    Report

    Report Number
    2031924-2011-00074
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. EVAL RESULTS: VISUAL INSPECTION OF THE LENS WAS CONDUCTED, TEARS WERE OBSERVED THROUGHOUT THE LENS (LENS RETURNED IN FOUR PIECES). ALSO, OBSERVED THAT A PORTION OF THE HAPTIC LOOP IS MISSING. DUE TO THE TORN CONDITION OF THE LENS, DIMENSIONAL MEASUREMENTS COULD NOT BE PERFORMED. IN ADDITION, ONE RETAIN SAMPLE FROM LOT # 019183 WAS INSPECTED DIMENSIONALLY AND ALL MEASUREMENTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE SURGEON REPORTS EXPLANTING THE CRYSTALENS IOL DUE TO DISLOCATION OF THE IOL LEADING TO DECREASED VISUAL FUNCTION APPROXIMATELY TWO MONTHS AFTER IMPLANTATION. CRYSTALENS WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A DIFFERENT IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH & LOMB AT50AO 019183

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention