BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIBA VISION MEMORYLENS

    MDR report key: 265146 · Received February 25, 2000

    Report

    Report Number
    2648166-2000-00030
    Event Type
    Injury
    Date Received
    February 25, 2000
    Date of Event
    December 7, 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 THREE 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.

    Description of Event or Problem · 1

    3/3/2000 - ADDITIONAL INFO RECEIVED FROM DR: THIS PARTICULAR PT HAD A PHACO CATARACT EXTRACTION, LEFT EYE IN 1999. THE PT SUBSEQUENTLY DEVELOPED WHAT THE SURGEON DESCRIBES AS A SEVERE ACUTE IRIDOCYCLITIS 12/14/1999; PT ALSO HAD RECURRING GLAUCOMA 12/14/1999 AS WELL AS VITRITIS; NO SECONDARY SURGERY WAS NECESSARY. AT PT'S LAST VISIT 2/21/2000 THE VISUAL ACUITY WAS AT 20/20 AND GIVEN A FAIR TO GOOD PROGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIBA VISION MEMORYLENS INTRAOCULAR LENS HQL CIBA VISION U940A 10201999

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR