BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS INTRAOCULAR LENS

    MDR report key: 4172844 · Received October 9, 2014

    Report

    Report Number
    2031924-2014-00266
    Event Type
    Injury
    Date Received
    October 9, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 LENS VAULTED ANTERIORLY AND ASYMMETRICALLY, APPROXIMATELY 14 WEEKS POST IMPLANTATION. THE 2+PCO AND MILD VERTICAL STRIAE WERE OBSERVED. THE PT NOTICED A DECREASE IN VISION. THE PT'S CURRENT PROGNOSIS AND TREATMENT WERE DESCRIBED AS: "MYOPIC WITH ASTIGMATISM. YAG PLANNED IN NEAR FUTURE". THIS EVENT PERTAINS TO THE PT'S LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO NEW INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637073 CRYSTALENS INTRAOCULAR LENS LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB AT50AO 7446608

    Patients

    Seq Age Sex Outcome Treatment
    1 Other