BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMORY LENS

    MDR report key: 1940615 · Received December 22, 2010

    Report

    Report Number
    2648694-2010-00015
    Event Type
    Injury
    Date Received
    December 22, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CIBA VISION CORP.
    Product Code
    HQL
    PMA / PMN Number
    P960036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS & STERILITY RECORDS HAVE BEEN REVIEWED BY MANUFACTURING AND FOUND TO BE IN COMPLIANCE. THIS LENS WAS MANUFACTURED BEFORE 04/2000 AND UNDERWENT A MODIFIED (BUFFERED TUMBLING) PROCESS DURING ITS MANUFACTURE. THE METHOD OF MANUFACTURE WAS SUBSEQUENTLY CHANGED TO ELIMINATE THE USE OF THIS MODIFIED PROCESS. THERE HAVE BEEN REPORTS OF BIOFILM FORMATION CAUSING OPACIFICATION OF LENSES WITH SERIAL NUMBERS THAT CORRESPOND TO THE USE OF THE MODIFIED (BUFFERED TUMBLING) PROCESS. (B)(4).

    Description of Event or Problem · 1

    AN EYE CARE PROFESSIONAL REPORTED THAT A MEMORY LENS IOL IMPLANTED IN THE LEFT EYE OF A PT, HAS SINCE OPACIFIED AND HAS BEEN EXPLANTED AND REPLACED. FOLLOW UP INFO RECEIVED ON (B)(6) 2010, REPORTED PT IS IN GOOD CONDITION AND SEEING WELL 4 DAYS POST-OP. THE DEVICE WAS IMPLANTED 7 YEARS AGO AND THE PT HAS EXPERIENCED PROGRESSIVELY DECREASING VISUAL ACUITY, LEFT EYE, OVER THE LAST 4 YEARS. FOLLOW UP INFO RECEIVED ON (B)(4) 2010 PROVIDED SURGICAL NOTES AND PT'S MEDICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMORY LENS INTRAOCULAR LENS HQL CIBA VISION CORP. U940A M431151

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention COUMADIN| METFORMIN| LISINOPRIL| NOVOLIN| NEXIUM| LOTREL| MULTI VITAMINS