BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS INTRAOCULAR LENS

    MDR report key: 4553409 · Received February 25, 2015

    Report

    Report Number
    1313525-2015-00255
    Event Type
    Injury
    Date Received
    February 25, 2015
    Date of Event
    September 25, 2014
    Report Date
    January 27, 2015
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO B+L. VISUAL INSPECTION FOUND PORTION OF A HAPTIC MISSING. DUE TO THE CONDITION IN WHICH THE LENS WAS RETURNED FURTHER TESTING COULD NOT BE PERFORMED. ONE RETAIN SAMPLE FROM THE SAME LOT (023147) WAS DIMENSIONALLY INSPECTED AND ALL MEASUREMENTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. BASED ON THE CURRENT INFORMATION, THE SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LENS WAS REPOSITIONED APPROXIMATELY 5 WEEKS POST IMPLANT DUE TO Z-SYNDROME AND CAPSULAR TENSION RING WAS INSERTED. HOWEVER Z-SYNDROME REOCCURRED ON (B)(6) 2015, AND SUBSEQUENTLY, THE LENS WAS EXCHANGED 5 MONTHS POST IMPLANT. ANOTHER MODEL LENS USED AS A REPLACEMENT. THE PATIENT'S CURRENT PROGNOSIS WAS DESCRIBED AS "EXCELLENT". THIS REPORT PERTAINS TO THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131271 CRYSTALENS INTRAOCULAR LENS LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH & LOMB, INC. AT50AO 023147

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other