BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON UV-ABSORBING SILICONE LENS

    MDR report key: 65030 · Received January 24, 1997

    Report

    Report Number
    2083358-1997-00002
    Event Type
    Injury
    Date Received
    January 24, 1997
    Date of Event
    November 29, 1996
    Report Date
    January 21, 1997
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM A PHYSICIAN OF A PT WHO UNDERWENT CATARACT EXTRACTION WITH IMPLANTATION OF THE MODEL 920 UV-ABSORBING SILICONE INTRAOCULAR LENS. AFTER IMPLANTATION, THE PT EXPERIENCED IMPAIRED VISUAL FUNCTION. THE LENS WAS FOUND TO HAVE PLAQUE ON THE SURFACE. YAG-COAGULATION 5EH WAS DONE ON 11/29/96. THE LENS WAS EXPLANTED ON 12/3/96 AND REPLACED WITH ANOTHER. SHE WAS PRESCRIBED SPERSADEXOLIN AND EYE DROPS ALTERNATING EVERY TWO HOURS. SHE HAS RECOVERED. LENS INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON UV-ABSORBING SILICONE LENS Implant INTRAOCULAR LENS HQL PHARMACIA IOVISION, INC. 920/24.0(D) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| R NO DATA PROVIDED.