BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON

    MDR report key: 445679 · Received February 27, 2003

    Report

    Report Number
    9614546-2003-00014
    Event Type
    Injury
    Date Received
    February 27, 2003
    Date of Event
    January 18, 2003
    Report Date
    February 27, 2003
    Manufacturer
    PHARMACIA & UPJOHN, GRONINGEN
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IRITIS[IRITIS]. SPONTANEOUS DEVICE REPORT, LOCAL REF #CA20031096, COMPLAINT # 2681, ARGUS NO. 2003148276CA. A PHYSICIAN REPORTED THAT PT WITH A BROWN IRIS AND HISTORY OF GLAUCOMA TREATED WITH XALATAN (LATANOPROST), UNDERWENT IMPLANTATION WITH CEEON LENS 913A. THE PT DEVELOPED IRITIS IN 2003. PT WAS THEN TREATED WITH PREDFORTE (PREDNISOLONE ACETATE) THREE TIMES DAILY; XALATAN WAS DISCONTINUED. NO DETAILS OF TREATMEMT START DATES AND DOSE WERE GIVEN. AT THE TIME OF THE REPORT THE PT HAD NOT RECOVERED. THIS CASE LACKS A SIGNIFICANT AMOUNT OF MEDICAL AND DIAGNOSTIC DATA NEEDED TO PROVIDE A MEANINGFUL/ACCURATE CAUSAL ASSESSMENT. FOLLOW UP INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON INTRAOCULAR LENS HQL PHARMACIA & UPJOHN, GRONINGEN 913A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention XALATAN UNK TO UNK.