BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1940562 · Received December 21, 2010

    Report

    Report Number
    2031924-2010-00239
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    April 1, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTRAOCULAR LENS REMAINS IMPLANTED. (B)(4).

    Description of Event or Problem · 1

    BAUSCH + LOMB RECEIVED AN ELECTRONIC MAIL COMMUNICATION FROM A CONSUMER WHO UNDERWENT IMPLANTATION OF THE CRYSTALENS INTRAOCULAR LENS IN BOTH EYES. POSTOPERATIVELY, THE PATIENT REPORTS THAT THE CRYSTALENS DOES NOT PROVIDE REASONABLE VISION DURING OPERATION OF HIS MOTORCYCLE, SPECIFICALLY FROM 55 TO 60 MILES PER HOUR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other