BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1901933 · Received November 12, 2010

    Report

    Report Number
    2028159-2010-02188
    Event Type
    Injury
    Date Received
    November 12, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE RETURNED FOR EVAL. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFO 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, UNK AT THIS TIME. THIS REPORT WAS MAILED TO FDA ON: (B)(6) 2010. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTED WHILE DOING AN ANTERIOR VITRECTOMY SECONDARY TO A POSTERIOR CAPSULAR TEAR (PC TEAR), THERE WAS NO IRRIGATION. THE NURSE SWITCHED FROM THE VITRECTOMY SCREEN TO ALLOW IRRIGATION TO START AGAIN AND THE CASE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE TECHNICIAN REPORTED, THE PC TEAR WAS SUBSEQUENT TO A SURGICAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention