BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2212588 · Received August 11, 2011

    Report

    Report Number
    2031924-2011-00130
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE SURGEON REPORTED EXPLANTING A CRYSTALENS INTRAOCULAR LENS FROM THE PATIENT'S EYE DUE TO THE PATIENT BEING DISSATISFIED WITH HER VISION. THE DATE OF THE EXPLANT IS UNKNOWN. THE CRYSTALENS IOL WAS REPLACED WITH A DIFFERENT IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT50AO 019058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention