BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEEON UV-ABSORBING LENS

    MDR report key: 147076 · Received January 30, 1998

    Report

    Report Number
    2030635-1998-00001
    Event Type
    Malfunction
    Date Received
    January 30, 1998
    Date of Event
    December 17, 1997
    Report Date
    January 6, 1998
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS REC'D FROM A SURGICAL NURSE ON BEHALF OF AN OPHTHALMOLOGIST REPORTING A MODEL 920 IOL WAS IMPLANTED POST CATARACT EXTRACTION, AND A BIG CRACK WAS NOTED ACROSS THE LENS. THE LENS WAS INSPECTED PRIOR TO IMPLANT AN NO ABNORMALITIES FOUND. SHE INDICATED THAT THE PHYSICIAN DID NOT SEE A CRACK IN THE LENS DURING THE FOLDING PROCESS. HOWEVER, AFTER RELEASING THE IOL FROM THE FOLDER, A BIG CRACK WAS NOTED. THE IOL WAS EXPLANTED DURING THE SAME SURGERY WITHOUT FURTHER INCIDENT. ANOTHER MODEL 920 IOL WAS IMPLANTED WITHOUT ANY PROBLEMS. THE NURSE INDICATED SHE WOULD RETURN THE IOL FOR EVALUATION. INVESTIGATION BY THE MFR IS PENDING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR