BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEEON UV-ABSORBING SILICONE LENS

    MDR report key: 44810 · Received October 18, 1996

    Report

    Report Number
    2083358-1996-00004
    Event Type
    Malfunction
    Date Received
    October 18, 1996
    Report Date
    October 18, 1996
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    HOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF BATCH RECORDS SHOWED THAT ALL RELEASE CRITERIA WERE MET. MANUFACTURER CONCLUSION: NO PRODUCT DEFECT FOUND. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    "THE LENS SPLIT ONCE INSIDE THE PT'S EYE". NO OTHER DETAILS WERE PROVIDED. IN FOLLOW-UP WITH THE INITIAL REPORTER, THE LENS REMAIN "IN SITU" AND THE CRACK OCCURRED IN THE HAPTIC NOT IN THE VISUAL FIELD. THE SURGEON DID NOT WISH TO PROVIDE ANY ADD'L INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK *