BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIBA VISION MEMORY LENS

    MDR report key: 521239 · Received February 9, 2004

    Report

    Report Number
    2648694-2004-00006
    Event Type
    Malfunction
    Date Received
    February 9, 2004
    Report Date
    January 15, 2004
    Manufacturer
    CIBA VISION CORP
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A MEMORY LENS IOL IMPLANTED IN A PT'S RIGHT EYE IN 2000 HAS SINCE OPACIFIED. VISUAL ACUITY IS REPORTED AS 20/80 OD AS OF NOV 2003. PROGNOSIS IS LISTED AS GUARDED PENDING LENS REPLACEMENT & THAT PT HAS HAD A POSTERIOR CAPSULOTOMY PERFORMED. PRE-EXISTING HISTORY OF RETINITIS PIGMENTOSA. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIBA VISION MEMORY LENS INTRAOCULAR LENS HQL CIBA VISION CORP U940A M377487

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR NONE REPORTED