BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SI30NB

    MDR report key: 1863299 · Received October 9, 2010

    Report

    Report Number
    2648035-2010-00189
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    June 30, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INTRAOCULAR LENS WAS DISCARDED BY THE SURGERY CENTER AND NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. ATTEMPTS TO DETERMINE THE SERIAL NUMBER OF THE LENS WERE UNSUCCESSFUL PRECLUDING A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR DEVICE. THE RESULTS OF OUR INVESTIGATION ARE INCONCLUSIVE AND WE ARE NOT ABLE TO CONFIRM THE OBSERVATION OR DETERMINE THE CAUSE OF THIS EVENT. WE WILL CONTINUE TO MONITOR AND TREND ALL REPORTS.

    Description of Event or Problem · 1

    A PATIENT REPORTED BY TELEPHONE THE REMOVAL AND REPLACEMENT OF HER INTRAOCULAR LENS. SHE STATED SHE WAS EXPERIENCING A DECREASE IN HER VISION AND HER PHYSICIAN TOLD HER THE LENS HAD TURNED CLOUDY. SHE WAS NOT ABLE TO GIVE ANY PRODUCT IDENTIFIERS OR CONFIRM IT WAS AN AMO LENS. IN FOLLOW-UP WITH HER PHYSICIAN HE IDENTIFIED THE MODEL BUT DID NOT KNOW THE SERIAL NUMBER. HE IMPLANTED AN ANTERIOR CHAMBER LENS FROM ANOTHER IOL MANUFACTURER WITHOUT COMPLICATION. THE EXPLANTED LENS WAS DISCARDED BY THE SURGERY CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI30NB MONOFOCAL IOL HQL ABBOTT MEDICAL OPTICS SI30NB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention