BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMDATING IOL

    MDR report key: 3113751 · Received May 10, 2013

    Report

    Report Number
    2031924-2013-00087
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    February 28, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 6 WEEKS POST IMPLANTATION. THE SURGEON REPOSITIONED THE LENS WITH NO COMPLICATIONS. LENS VAULTING WAS NOTED AGAIN AT ONE MONTH AFTER THE REPOSITIONING. THE SURGEON CUT AND EXPLANTED THE LENS THREE MONTHS POST IMPLANT TO ADDRESS THE ISSUE. THE LENS WAS DISCARDED OF BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205323 CRYSTALENS ACCOMMDATING IOL NAA/LENS, INTRAOCULAR, ACCOMODATIVE NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other