BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMDATING IOL

    MDR report key: 3113744 · Received May 10, 2013

    Report

    Report Number
    2031924-2013-00085
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    March 4, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS BEEN RETURNED TO B+L AND IS CURRENTLY UNDER EVALUATION. 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 SIGNIFICANT CAPSULAR FIBROSIS CAUSING LENS VAULTING WAS NOTED APPROXIMATELY SIX WEEKS AFTER IMPLANTATION. PATIENT ALSO COMPLAINED OF DECREASE IN VISION. THE SURGEON MADE AN ATTEMPT TO REPOSITION THE LENS, BUT WAS NOT SUCCESSFUL. APPROXIMATELY THREE MONTHS AFTER LENS IMPLANT THE SURGEON CUT MOST OF THE LENS, BUT ONE HAPTIC COULD NOT BE REMOVED. HE REPLACED THE LENS WITH A 3 PIECE LENS. THIS REPORT PERTAINS TO THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208966 CRYSTALENS ACCOMMDATING IOL NAA/LENS, INTRAOCULAR, ACCOMODATIVE NAA BAUSCH + LOMB AT52AO

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other