BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON LENS

    MDR report key: 239468 · Received September 8, 1999

    Report

    Report Number
    9614546-1999-00038
    Event Type
    Injury
    Date Received
    September 8, 1999
    Date of Event
    July 20, 1999
    Report Date
    September 8, 1999
    Manufacturer
    PHARMACIA BV PRODUCTION
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED VIA A RETURN OF CEE ON LENS MODEL 912/18 (D). ADDITIONAL INFORMATION WAS PROVIDED BY THE PHYSICIAN'S ASSISTANT. THIS 68 YEAR OLD FEMALE HAD THE 912/18 (D) LENS IMPLANTED IN HER LEFT EYE IN 1999. AT HER FOLLOW-UP VISITS ON ONE DAY AND ONE WEEK POST IMPLANT, HER VISION WAS "WAY OFF". THIS LENS WAS EXPLANTED AND ANOTHER LENS DIOPTER 13.5 WAS IMPLANTED. THE LENS WAS RETURNED TO VERIFY THE POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON LENS Implant INTRAOCULAR LENS HQL PHARMACIA BV PRODUCTION 912 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention