BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEEON LENS

    MDR report key: 169311 · Received May 22, 1998

    Report

    Report Number
    2030635-1998-00013
    Event Type
    Malfunction
    Date Received
    May 22, 1998
    Report Date
    May 22, 1998
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS REC'D FROM AN OPHTHALMOLOGIST CONCERNING THE MODEL 912 INTRAOCULAR LENS. HE RETURNED THE INTRAOCULAR LENS INDICATING THAT IT WAS INSERTED AND REMOVED AND IT APPEARED TO BE "FAULTY & FRACTURED". A MODEL 912 INTRAOCULAR LENS WAS IMPLANTED INTO A PT'S EYE. AFTER IMPLANTATION, IT WAS NOTED THAT THE HAPTIC WAS LOOSE. HE GRABBED THE INTRAOCULAR LENS AND THE HAPTIC BROKE. HE REMOVED THE INTRAOCULAR LENS WITHOUT INCIDENT OR FURTHER INJURY TO THE PT AND IMPLANTED ANOTHER INTRAOCULAR LENS. THE INTRAOCULAR LENS HAS BEEN RETURNED FOR INVESTIGATION AND THE INVESTIGATION BY THE MFR IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON LENS Implant INTRAOCULAR LENS HQL PHARMACIA IOVISION, INC. 912 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other ANTIDIABETIC MED, ANTIHYPERTENSIVE MED.