BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS INTRAOCULAR LENS

    MDR report key: 4101605 · Received August 27, 2014

    Report

    Report Number
    2031924-2014-00214
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 29, 2014
    Manufacturer
    BAUSCH + LOMB SURGICAL
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED 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 PRESENTED WITH Z-SYNDROME APPROXIMATELY 6 WEEKS POST IOL IMPLANTATION IN THE LEFT EYE. REPORTEDLY THE PATIENT NOTICED A DECREASE IN VISION. ON (B)(6) 2014, THE LENS WAS REPOSITIONED AND CAPSULAR TENSION RING WAS PLACED. SUBSEQUENTLY, THE LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL LENS. IN THE SURGEON'S OPINION THE LIKELY CAUSE OF THE EVENT WAS CAPSULAR CONTRACTION SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522617 CRYSTALENS INTRAOCULAR LENS LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB SURGICAL AT-50AO 7443714

    Patients

    Seq Age Sex Outcome Treatment
    1 Other