BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 3123627 · Received May 17, 2013

    Report

    Report Number
    2031924-2013-00097
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    February 12, 2013
    Report Date
    April 18, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED THEREFORE IT WILL NOT BE RETURNED TO BAUSCH + LOMB FOR 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 APPROXIMATELY ONE WEEK AFTER LENS IMPLANTATION, THE PATIENT DEVELOPED UVEITIS. DURING THE SURGERY, THE SURGEON NOTED THAT THE CAPSULE BAG WAS "SLIGHTLY TIGHT" FOLLOWING LENS INSERTION AND ROTATION. THE PATIENT WAS TREATED WITH STEROIDS. THERE WAS NO LOSS OF BCVA REPORTED. THIS REPORT PERTAINS TO THE PATIENT'S RIGHT EYE. PLEASE REFERENCE MDR# 2031924-2013-00096 FOR THE INTRAOCULAR LENS USED IN THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219366 CRYSTALENS ACCOMMODATING IOL NAA / LENS INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other