BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIBA VISION MEMORY LENS

    MDR report key: 1023483 · Received April 2, 2008

    Report

    Report Number
    2648694-2008-00001
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 6, 2008
    Manufacturer
    CIBA VISION CORP.
    Product Code
    HQL
    PMA / PMN Number
    P960036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS & STERILITY RECORDS HAVE BEEN REVIEWED BY MFG AND FOUND TO BE IN COMPLIANCE.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A CV232SRE IOL IMPLANTED IN THE RIGHT EYE OF A PT, HAS SINCE OPACIFIED. CURRENT BEST CORRECTED LEFT EYE ACUITY REPORTED AS 20/30+. GOOD PROGNOSIS NOTED. REPLACEMENT OF IOL HAS NOT BEEN SCHEDULED AT THIS TIME, BUT IS EXPECTED IN THE FUTURE. NO FURTHER INFO HAS BEEN PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIBA VISION MEMORY LENS INTRAOCULAR LENS HQL CIBA VISION CORP. CV232SRE S025796

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED