BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON UV-ABSORBING PC IOL

    MDR report key: 160141 · Received March 27, 1998

    Report

    Report Number
    2030635-1998-00009
    Event Type
    Injury
    Date Received
    March 27, 1998
    Date of Event
    January 20, 1998
    Report Date
    March 10, 1998
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CO REC'D A REPORT WHEN A LENS WAS RETURNED. AN OPHTHALMOLOGIST REPORTED THAT A MODEL 920, 16.0 D LENS HAD BEEN IMPLANTED THEN EXPLANTED BECAUSE THE HEPATIC WAS SPINNING AROUND AT THE SITE OF INSERTION IN THE OPTIC. HE DID NOT WANT TO MANIPULATE IT INTO THE PROPER POSITION FOR FEAR OF BREAKING THE HEPATIC. THIS PHYSICIAN WAS CONTACTED BY PHONE AND HE SAID THAT HE HAD TO MAKE A SLIGHTLY LARGER INCISION IN ORDER TO REMOVE THE MODEL 920 AND THAT HE HAD REPLACED IT WITH ANOTHER MFR'S LENS. THE PT MADE A FULL RECOVERY FROM THE SURGERY. A FOLDER PROVIDED BY PHARMACIA & UPJOHN WAS USED IN THE PROCEDURE. THE SURGEON COMMENTED THAT THE MODEL 920 WAS NOT HIS LENS OF CHOICE. HE BELIEVES THE HAPTICS ARE NOT WELDED PROPERLY TO THE OPTIC. HE ALSO SAID THE LENS IS TOO HARD TO MANIPULATE AND HE HAS TO FOLD IT UNDER THE MICROSCOPE BUT IS USUALLY SUCCESSFUL. AN EVALUATION OF THE RETURNED LENS AND A BATCH REVIEW HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON UV-ABSORBING PC IOL Implant 3 PIECE FOLDABLE PC IOL HQL PHARMACIA IOVISION, INC. 920 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other