BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALEN AO

    MDR report key: 2010937 · Received March 4, 2011

    Report

    Report Number
    2031924-2011-00052
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BAUSCH + LOMB
    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 DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. ACCORDING TO THE SURGEON, THE BENT HAPTIC WAS LIKELY DUE TO THE LENS INJECTOR. HOWEVER, NEITHER THE LENS NOR THE INJECTOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF A CRYSTALENS IOL INTO THE PATIENT'S LEFT EYE. THE SURGEON ATTEMPTED TO INJECT THE LENS THROUGH A 2.4 MM INCISION; HOWEVER, AFTER SEVERAL ATTEMPTS, THE TRAILING HAPTIC WAS BENT. THE INCISION WAS ENLARGED TO 3.0 MM AND A NEW LENS WAS IMPLANTED WITHOUT ANY REPORTED COMPLICATIONS. REFERENCE MDR: 2031924-2011-00053.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALEN AO INTRAOCULAR LENS NAA BAUSCH + LOMB AT50AO 018875

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention PROVISC| BSS (ALCON)| DUOVISC| CI-28 DELIVERY DEVICE (B+L)