BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMDATING IOL

    MDR report key: 3113750 · Received May 10, 2013

    Report

    Report Number
    2031924-2013-00086
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ASYMMETRICAL LENS VAULTING WAS NOTED APPROXIMATELY THREE MONTHS POST IMPLANTATION. THE SURGEON REPOSITIONED THE LENS AND IMPLANTED A CAPSULAR TENSION RING (CTR) BUT HE WAS NOT SUCCESSFUL. A DIFFERENT SURGEON EXPLANTED THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208968 CRYSTALENS ACCOMMDATING IOL NAA/LENS, INTRAOCULAR, ACCOMODATIVE NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other