BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIBA VISION MEMORYLENS

    MDR report key: 351161 · Received September 11, 2001

    Report

    Report Number
    2648166-2001-00031
    Event Type
    Other
    Date Received
    September 11, 2001
    Date of Event
    June 25, 2001
    Report Date
    September 11, 2001
    Manufacturer
    CIBA VISION CORP.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED IN 08/2001 FROM THE OPERATING ROOM CHARGE NURSE AT THE HOSP, STATING THAT A MEMORYLENS HAD BEEN IMPLANTED IN PT'S RIGHT EYE 2 MONTHS PRIOR. THE PT PRESENTED FOR EXAMINATION ON 4TH DAY POST IMPLANT AND WAS DIAGNOSED WITH HYPOPYON AND INTRAOCULAR INFECTION. A VITREOUS ASPIRATION (TAP) WAS PERFORMED ON THE PT'S EYE FOR A CULTURE FOR EXAMINATION AND DIAGNOSIS: THE CULTURE SHOWED STAPHYLOCOCCUS EPIDERMIDIS. THE PT WAS PUT ON STEROIDS AND ANTIBIOTICS. THE PT'S VISUAL ACUITY AS OF 08/2001 WAS 20/80 OD. THE SURGEON'S PROGNOSIS FOR THE PT WAS LISTED AS FAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41190 CIBA VISION MEMORYLENS INTRAOCULAR LENS HQL CIBA VISION CORP. U940S1 M577827

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other NONE REPORTED.