BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2061165 · Received March 3, 2011

    Report

    Report Number
    2028159-2011-00229
    Event Type
    Other
    Date Received
    March 3, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 11, 2011
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS EXPECTED TO RETURN, AS THE SLEEVE WAS TORN DURING THE EXCHANGE OF THE SLEEVE. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER GENERATED MEDWATCH FORM WAS REC'D. THE REPORT INDICATES THAT THE SURGEON WAS PERFORMING PHACOEMULSIFICATION WHEN THE SURGEON AND OPERATING ROOM TECHNICIAN NOTED WHAT THEY INITIALLY THOUGHT WAS BALANCED SALT SOLUTION SPRAYING OUT OF THE INCISION. IT WAS REALIZED WHAT THEY WERE SEEING WAS ACTUALLY SMOKE. THE SURGEON REMOVED THE HANDPIECE AND EXAMINED THE TIP. THE SURGEON STATES SHE SAW A BUBBLE OF FLUID COMING OUT OF THE SIDE OF THE SLEEVE OF THE PHACO TIP, INDICATING POSSIBLE MICRO PERFORATION OF THE SLEEVE. SURGEON ALSO STATED THAT THERE WAS A SMALL CORNEAL BURN AS A RESULT. A NEW SLEEVE WAS PLACED OVER THE TIP AND THE SURGERY PROCEEDED W/O INCIDENT. THE SLEEVE WAS RETRIEVED AFTER SURGERY, BUT IT HAD BEEN TORN DURING THE SLEEVE EXCHANGE AND A MICRO PERFORATION WOULD NOT BE ABLE TO BE SEEN. THE SURGEON STATES SHE BELIEVES THE PT WILL BE FINE.

    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 65 YR Other