BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1991076 · Received February 11, 2011

    Report

    Report Number
    2031924-2011-00039
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    June 1, 2007
    Report Date
    January 13, 2011
    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

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. THE INTRAOCULAR LENS IS IMPLANTED.

    Description of Event or Problem · 1

    BAUSCH AND LOMB RECEIVED A COMMUNICATION FROM A CONSUMER WHO UNDERWENT BILATERAL IMPLANTATION OF THE CRYSTALENS INTRAOCULAR LENS. THIS REPORT REFERS TO THE LEFT EYE. POSTOPERATIVELY, THE PT REPORTS EXPERIENCING DIPLOPIA WHEN SEEING THROUGH BOTH EYES. THE PT HAS BEEN PRESCRIBED IN AN ATTEMPT TO RESOLVE THE ISSUE. ADD'L INFO HAS BEEN REQUESTED. REFERENCE MDR #2031924-2011-00040.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH & LOMB AT50SE 007208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other