BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIBA VISION MEMORYLENS

    MDR report key: 267190 · Received March 7, 2000

    Report

    Report Number
    2648166-2000-00057
    Event Type
    Injury
    Date Received
    March 7, 2000
    Date of Event
    November 6, 1999
    Manufacturer
    CIBA VISION
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN HAS HAD FIVE OCCURRENCES OF INFLAMMATION REACTION ASSOCIATED WITH MODEL U940A UV-ABSORBING HYDROPHILIC, POSTERIOR CHAMBER INTRAOCULAR LENS. TO DATE CO HAS NOT RECEIVED THE PARTICULAR DETAILS RELATING TO THIS SPECIFIC CONTROL NUMBER. MARCH 3, 2000-ADDITIONAL INFO RECEIVED FROM PHYSICIAN. THIS PARTICULAR PT HAD A PHACO CATARACT EXTRACTION, LEFT EYE 1999. THE PT SUBSEQUENTLY DEVELOPED WHAT THE SURGEON DESCRIBES AS A SEVERE ACUTE CORNEAL DECOMPENSATION 12/10/99; NO SECONDARY SURGERY WAS NECESSARY; THE CORNEA WAS CLEAR 1 DAY POST-OP WITH SOME EDEMA 11/24/99 THAT WENT TO SEVERE EDEMA 12/10/99. DR STATES THAT RELATIVELY LOWER CELL COUNT BUT CLEAR CORNEA POST-OPERTIVE & NORMAL INTRAOCULAR PRESSURE SUGGESTS SURGERY NOT RESPONSIBLE. AT PT'S LAST VISIT 12/15/99 THE VISUAL ACUITY WAS AT 20/400 AND GIVEN A POOR PROGNOSIS AND WAS AWAITING "PKO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIBA VISION MEMORYLENS INTRAOCULAR HQL CIBA VISION U940A 10061999

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR