BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEE ON LENS

    MDR report key: 160139 · Received March 27, 1998

    Report

    Report Number
    2030635-1998-00008
    Event Type
    Injury
    Date Received
    March 27, 1998
    Date of Event
    February 26, 1998
    Report Date
    March 2, 1998
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED VIA A PHARMACIA & UPJOHN SALES REPRESENTATIVE FROM AN OPHTHALMOLOGIST REQUESTING INFO CONCERNING THE MODEL 912 IOL. A PT HAD A CATARACT EXTRACTION AND LENS IMPLANT ON FEB 19, 1998/ ABOUT ONE WEEK LATER, THE PT COMPLAINED OF PHOTOPHOBIA. THE OPHTHALMOLOGIST PERFORMED ANOTHER SURGERY IN WHICH HE SCRAPPED A GELATINOUS SUBSTANCE OFF THE IOL. THE IOL WAS NOT EXPLANTED. MULTIPLE ATTEMPTS TO OBTAIN ADD'L INFO FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention