BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON

    MDR report key: 360205 · Received November 5, 2001

    Report

    Report Number
    9614546-2001-00021
    Event Type
    Injury
    Date Received
    November 5, 2001
    Date of Event
    August 26, 1999
    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-N ARGUS NO2001078285US. A PT WITH GLAUCOMA IN BOTH EYES, UNDEREWENT IN 1992 A PHACO/INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE, AND DEVELOPED IN 1999 THE PHACODONESIS OF IOL (ONE PIECE PMMA -POLY(METHYL)METHACRYLATE). CONSEQUENTLY THE PATIENT UNDERWENT INTERVENTION EXCHANGED WITH ANTERIOR CHAMBER (AC) IOL. IN THE MEDICAL HISTORY THE PT HAD LASER POSTERIOR CAPSULOTOMY IN THE RIGHT EYE (YAC) IN 1992 AND 1994. THE OUTCOME WAS REPORTED AS RECOVERING/RESOLVING WITH THE BEST CORRECTED VISUAL ACUITY (BCVA) 20/20 (6 MONTHS POSTOPERATIVE; PUPILLARY BLOCK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49364 CEEON INTRAOCULAR LENS HQL PHARMACIA & UPJOHN, GRONINGEN U37WB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O| R