BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIBA VISION MEMORY LENS

    MDR report key: 568970 · Received January 31, 2005

    Report

    Report Number
    2648694-2005-00006
    Event Type
    Injury
    Date Received
    January 31, 2005
    Date of Event
    October 29, 2004
    Report Date
    January 1, 2005
    Manufacturer
    CIBA VISION PUERTO RICO, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A MEMORY LENS IOL IMPLANTED IN THE LEFT EYE OF A PT IN 2000 HAS SINCE OPACIFIED. THE LENS WAS EXPLANTED AND REPLACED IN 2005 WITH NO COMPLICATIONS AND PT DOING WELL. VISUAL ACUITY REPORTED AS 20/100-1, OS, ATS FIVE DAY FOLLOW UP WITH EXCELLENT PROGNOSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIBA VISION MEMORY LENS INTRAOCULAR LENS HQL CIBA VISION PUERTO RICO, INC. U940A M434584

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention NONE REPORTED.