BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS INTRAOCULAR LENS

    MDR report key: 4212959 · Received October 24, 2014

    Report

    Report Number
    2031924-2014-00278
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED, THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED WITH HIS NEAR AND INTERMEDIATE VISION. THE LENS WAS NOTED TO BE VAULTING POSTERIORLY. THE DOCTOR IS EVALUATING TREATMENT OPTIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. THIS REPORT PERTAINS TO THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678053 CRYSTALENS INTRAOCULAR LENS LENS, INTRAOCULAR, ACCOMODATIVE NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other