BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 3121931 · Received May 15, 2013

    Report

    Report Number
    2031924-2013-00088
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 30, 2012
    Report Date
    April 15, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 APPROXIMATELY TWENTY DAYS AFTER LENS IMPLANTATION THE PT PRESENTED WITH DECREASED VISUAL ACUITY. THE PT WAS DIAGNOSED WITH "Z" SYNDROME. THE SURGEON ATTEMPTED TO REPOSITION THE LENS. THE LENS WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A DIFFERENT MODEL LENS. ACCORDING TO THE SURGEON, THE PT'S VISION IS GREATLY IMPROVED. THIS REPORT PERTAINS TO THE PT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215297 CRYSTALENS ACCOMMODATING IOL NAA/LENS INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other