BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS INTRAOCULAR LENS

    MDR report key: 4938206 · Received July 22, 2015

    Report

    Report Number
    1313525-2015-02134
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    December 19, 2014
    Report Date
    January 28, 2015
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS NOT RETURNED FOR EVALUATION. A RETAIN SAMPLE FROM THE SAME LOT (7445513) WAS DIMENSIONAL INSPECTED AND ALL DIMENSIONALLY MEASUREMENTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NONCONFORMITIES OR ANOMALIES RELATED TO THIS COMPLAINT WERE FOUND. BASED ON THE CURRENT INFORMATION RECEIVED, A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH Z-SYNDROME AND CAPSULAR CONTRACTURE SYNDROME. THE LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL LENS. THIS EVENT REFERS TO THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475622 CRYSTALENS INTRAOCULAR LENS LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH & LOMB, INC. AT50AO 7445513

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other