BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON

    MDR report key: 401491 · Received June 21, 2002

    Report

    Report Number
    9614546-2002-00021
    Event Type
    Injury
    Date Received
    June 21, 2002
    Report Date
    June 21, 2002
    Manufacturer
    PHARMACIA & UPJOHN, GRONINGEN
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MALPOSITIONED INTRAOCULAR LENSES (LENS DISLOCATION). UVEITIS [UVEITIS NOS]. GLAUCOMA [GLAUCOMA NOS]. HYPHEMA [HYPHAEMA]. CASES DESCRIPTION: SPONTANEOUS LITERATURE, LOCAL REF.N. 02-00468, ARGUS N. 2002111385US. A LITERATURE PAPER (AM.J. OPHTHALMOL; 133(6); 839-41; 2002) REPORTED A CASE REGARDING A PT WHO UNDERWENT A LENS IMPLANTATION FOR CATARACT EXTRACTION ON UNK DATE. ONE MONTH AFTER THE SURGICAL INTERVENTION, THE PT DEVELOPED UVEITIS-GLAUCOMA-HYPHEMA SYNDROME OF THE LEFT EYE. UVEITIS-GLAUCOMA-HYPHEMA SYNDROME CAN LEAD TO LOSS OF VISION FROM GLAUCOMATOUS OPTIC NEUROPATHY, CHRONIC INFLAMMATION, CYSTOID MASCULAR EDEMA, AND INTRAOCULAR HEMORRHAGE. SURGICAL INTERVENTION IS OFTEN REQUIRED TO RESTORE NORMAL INTRAOCULAR ANATOMY, REPLACE POORLY POSITIONED INTRAOCULAR LENSES, OR CONTROL GLAUCOMA. AN ULTRASOUND BIOMICROSCOPY, REVEALED A LENS MALPOSITION, IN WHICH THE HAPTICS WERE LOCATED IN THE CILIARY SULCUS AND WERE IN CONTACT WITH THE IRIS PIGMENT EPITHELIUM. THE OUTCOME IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON INTRAOCULAR LENS HQL PHARMACIA & UPJOHN, GRONINGEN 912 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention| S