BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL II

    MDR report key: 1941896 · Received December 17, 2010

    Report

    Report Number
    2028159-2010-02390
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO SAMPLE AVAILABLE FOR IN-HOUSE EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT PRESENTED WITH AN INTRAOCULAR FOREIGN BODY, WITHIN THE SOEMMERING'S RING, AFTER CATARACT SURGERY. THE FOREIGN BODY WAS NOTED IN (B)(6) 2010. THERE WAS NO TRAUMA TO THE PATIENT REPORTED. THE PATIENT UNDERWENT CATARACT SURGERY IN 2004 AND HAS NOT HAD ANY ADDITIONAL OCULAR PROCEDURES SINCE THEN. THE FOREIGN BODY WAS DETERMINED TO BE SILVER. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO DETERMINE PATIENT STATUS, IF ANY ADDITIONAL SURGERIES OR TREATMENTS WERE DONE AND/OR IF THE FOREIGN BODY REMAINS IN THE PATIENT'S EYE. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL II PHACOEMULSIFICATION SYSTEM HQC ALCON-IRVINE TECHNOLOGY CENTER UNIV II NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other