BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2133477 · Received June 15, 2011

    Report

    Report Number
    2031924-2011-00115
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 IS IMPLANTED, THEREFORE IT IS NOT AVAILABLE FOR EVAL. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE SURGEON REPORTS THAT TWO WEEKS POST IMPLANTATION OF AN AT50AO LENS IN THE PT'S RIGHT EYE, ANTERIOR ASYMMETRICAL TILTING OF THE IOL WAS NOTED, AND THE PT NOTICED A CHANGE IN HIS VISION. THE LENS WAS SUCCESSFULLY REPOSITIONED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT50AO 019069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention