BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1907077 · Received November 9, 2010

    Report

    Report Number
    2031924-2010-00198
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 3, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE RIGHT EYE. APPROXIMATELY TWO MONTHS POSTOPERATIVELY, THE LENS VAULTED AND THE PT EXPERIENCED A SUDDEN ONSET OF BLURRED VISION. THE PT'S CURRENT UNCORRECTED VISUAL ACUITY IS 20/200 AND PINHOLE CORRECTION IS 20/40 WITH MR -1.75 - 2.75 X 011. THE SLIT-LAMP EXAMINATION REVEALED THE IOL WAS IMPLANTED IN THE CAPSULAR BAG BUT WITH CAPSULAR FIBROSIS, PCO AND STRESS LINES. THE LENS WAS TILTED ANTERIORLY AT THE 6 O'CLOCK POSITION. THE LENS REMAINS IMPLANTED, HOWEVER, A YAG CAPSULOTOMY, SURGICAL LYSIS OF FIBROUS BANDS, AND LENS EXCHANGE ARE BEING CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH & LOMB HD500

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention