BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON

    MDR report key: 360172 · Received November 5, 2001

    Report

    Report Number
    9614546-2001-00020
    Event Type
    Injury
    Date Received
    November 5, 2001
    Date of Event
    February 20, 1996
    Report Date
    November 5, 2001
    Manufacturer
    PHARMACIA & UPJOHN, GRONINGEN
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS LATE DISLOCATION OF LENS [LENS DISLOCATION]. CASE DESCRIPTION: SPONTANEOUS-LITERATURE CASE/US LOCLOGNO. AN-01-0078-F ARGUS NO2001078287US. A PT WHO UNDERWENT IN 1991 A PHACO/INTRAOCULAR LENS (IOL)IMPLANTATION IN THE LEFT EYE, DEVELOPED IN 1995 THE INFERIOR DISPLACEMENT OF IOL (ONE PIECE PMMA -POLY(METHYL)METHACRYLATE). CONSEQUENTLY THE PT UNDERWENT THE ANTERIOR VITRECTOMY EXCHANGED WITH ANTERIOR CHAMBER (AC) IOL. IN THE MEDICAL HISTORY THE PT HAD LASER POSTERIOR CAPSULOTOMY IN THE LEFT EYE (YAC) IN 1995. THE OUTCOME WAS REPORTED AS RECOVERING/RESOLVING WITH THE BEST CORECTED VISUAL ACUITY (BCVA) 20/30 (3 YEARS POSTOPERATIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49374 CEEON INTRAOCULAR LENS HQL PHARMACIA & UPJOHN, GRONINGEN U37WB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R