BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMODATING IOL

    MDR report key: 3037333 · Received April 1, 2013

    Report

    Report Number
    2031924-2013-00066
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO B+L. VISUAL INSPECTION OF THE RETURNED LENS FOUND THE HAPTICS BENT AND A TEAR A THE LEADING HAPTIC PLATE. DIMENSIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED LENS. ONE RETAIN SAMPLE FROM THE SAME LOT (021911) WAS DIMENSIONALLY INSPECTED AND ALL MEASUREMENTS WERE WITHIN SPECIFICATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS REMOVED FROM THE PATIENT'S LEFT EYE INTRAOPERATIVELY DUE TO RADIAL TEAR OF THE ANTERIOR CAPSULE NOTED UPON INSERTION. THE TEAR PROPAGATED PERIPHERALLY TOWARDS POSTERIOR CAPSULE. A MONOFOCAL LENS WAS IMPLANTED AND NO REPORTED POSTOPERATIVE SEQUELAE. PLEASE REFERENCE MDR:: 20131924-2013-00065, FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132948 CRYSTALENS ACCOMODATING IOL NAA/LENS, INTRAOCULAR, ACCOMADATIVE NAA BAUSCH + LOMB AT52AO 021911

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other CRYSTALSERT DELIVERY SYSTEM, CI-28