BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEEON UV-ABSORBING SILICONE LENS

    MDR report key: 121892 · Received September 17, 1997

    Report

    Report Number
    2083358-1997-00010
    Event Type
    Malfunction
    Date Received
    September 17, 1997
    Date of Event
    August 1, 1997
    Report Date
    August 21, 1997
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    HOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS REC'D FROM A PHYSICIAN ON THE MODEL 920 LENS. SHE WAS ATTEMPTING TO FOLD THE LENS WITH A SMALL INSERTER AND THE LENS CRACKED. PHARMACIA & UPJOHN HAS DETERMINED THIS TO BE A PRODUCT MALFUNCTION AS IT IS NOT IN THE LABELING. THE PHYSICIAN INDICATED THAT SHE DID NOT IMPLANT THIS LENS AND WOULD NOT IMPLANT IN IOL THAT SHE COULD SEE A DEFECT IN. AWAIT RESULTS OF A MFR BATCH REVIEW OF THIS IOL.

    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 * Other