BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIBA VISION MEMORYLENS

    MDR report key: 391570 · Received April 30, 2002

    Report

    Report Number
    2648166-2002-00030
    Event Type
    Malfunction
    Date Received
    April 30, 2002
    Date of Event
    March 28, 2002
    Report Date
    April 2, 2002
    Manufacturer
    CIBA VISION CORP.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A DOCTOR REGARDING A MEMORYLENS WHICH HAS A TRACE OF OPACIFICATION. THE IOL WAS IMPLANTED IN THE PATIENT'S RIGHT EYE IN 2000. AT EXAM IN 2002, THE PATIENT'S VISUAL ACUITY WAS REPORTED AS 20/70 OD WITH GLARE. PATIENT HAS A PRE-EXISTING MEDICAL HISTORY OF DIABETES, HTN, OHD-CAD, AMD AND ERM. THE DOCTOR IS NOT PLANNING ON EXPLANTING THE LENS AT THIS POINT IN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIBA VISION MEMORYLENS INTRAOCULAR LENS HQL CIBA VISION CORP. U940A *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR ACCUPRIL,ASA, NORVAC, ZOCOR, TRIAM.