BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2040948 · Received March 25, 2011

    Report

    Report Number
    2031924-2011-00077
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 21, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: VISUAL INSPECTION OF THE RETURNED LENS REVEALED A TEAR THROUGHOUT THE OPTIC AND A TEAR THROUGHOUT THE TRAILING HAPTIC PLATE AND ONE TEAR ON THE EDGE. ALSO, OBSERVED ENTIRE LEADING HAPTIC PLATE AND PARTIAL PORTION OF THE OPTIC ARE MISSING. UNABLE TO PERFORM DIMENSIONAL MEASUREMENTS DUE TO THE TORN CONDITION OF THE LENS. IN ADDITION, ONE RETAIN SAMPLE FROM LOT # 018763 WAS INSPECTED DIMENSIONALLY AND ALL MEASUREMENTS WERE WITHIN SPECS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. RESULTS: UNABLE TO PERFORM DIMENSIONAL MEASUREMENTS DUE TO THE TORN CONDITION OF THE LENS. IN ADDITION, ONE RETAIN SAMPLE FROM LOT # 018763 WAS INSPECTED DIMENSIONALLY AND ALL MEASUREMENTS WERE WITHIN SPECS.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE CRYSTALENS IOL IN THE RIGHT EYE. WHILE ADVANCING THE LENS, THE SURGEON NOTICED THAT THE LENS HAD TORN AT THE EDGE WHERE THE OPTIC MEETS THE HAPTIC. THE IOL WAS REMOVED THROUGH AN ENLARGED INCISION AND THE WOUND WAS CLOSED WITH A SUTURE. ANOTHER CRYSTALENS IOL WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT50AO 018763

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention