BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 3931410 · Received June 26, 2014

    Report

    Report Number
    2031924-2014-00140
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED, THEREFORE, IT IS NOT AVAILABLE 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 4 WEEKS POST IMPLANT THE LENS VAULTED ANTERIORLY. THE LENS WAS REPOSITIONED USING CAPSULAR TENSION RING (CTR). SUTURE WAS USED TO CLOSE THE WOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372952 CRYSTALENS ACCOMMODATING IOL NAA/LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other