BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2133476 · Received June 15, 2011

    Report

    Report Number
    2031924-2011-00116
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 20, 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. IN THE SURGEON'S OPINION THE MOST LIKELY CAUSE OF THE EVENT WAS DUE TO JAMMING OF THE IOL IN THE INJECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAPTIC BROKE UPON INSERTING THE AT50AO IOL INTO THE PT'S LEFT EYE. ACCORDING TO THE INFO RECEIVED, THE PT WAS MOVING DURING IMPLANTATION. SUBSEQUENTLY, THE SURGEON MADE AN INCISION TO REMOVE THE LENS, AND IMPLANTED A BACKUP LENS SUCCESSFULLY. THE PT WAS DOING FINE AND THE PROGNOSIS WAS DESCRIBED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT50AO 018848

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention AMO SILVER SERIES UNFOLDER WITH WINGS.