BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2961701 · Received February 11, 2013

    Report

    Report Number
    2028159-2013-00214
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ALCON 0 IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF (B)(4); THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. AS THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER, DHR (DEVICE HISTORY RECORD) AND LOT HISTORY COULD NOT BE REVIEWED. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; VISUAL INSPECTION OF FUNCTIONAL TESTING COULD NOT BE CONDUCTED. WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. CONSUMABLES MANUFACTURING HAS BEEN MADE AWARE OF THIS COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED ISSUES WITH I/A (IRRIGATION/ASPIRATION) PERFORMANCE DURING MULTIPLE CATARACT PROCEDURES WHICH WERE PERFORMED BY DIFFERENT SURGEONS OVER A PERIOD OF THREE WEEKS. THERE WAS BLOCKAGE OF THE FLOW AT THE END OF THE HANDPIECE INTO THE EYE CREATING A SHALLOWING OF THE CHAMBER, BUT ONLY DURING I/A AND VISCOELASTIC REMOVAL MODES. IT WAS ALSO NOTED THAT THE FLOW DID NOT APPEAR TO BE CONSISTENT WITH THE I/A HANDPIECE AND SLEEVE CONFIGURATION WHEN USING A 2.2 MM KERATOME. IT WAS REPORTED THAT THERE WAS NO CRIMPING OF THE TUBE AND THE SLEEVE SEEMED VERY TIGHT, BUT THE FLUID WOULD ONLY TRICKLE OUT OF THE I/A TIP. EXCHANGING THE HANDPIECES AND TIPS DID NOT RESOLVE THE PROBLEM. GOOD IRRIGATION FLOW WAS NOTED WHEN THE TUBING WAS RELEASED FROM THE I/A HANDPIECE. THE SURGEON SUSPECTED THAT THE SLEEVE COULD POSSIBLY BE RESPONSIBLE FOR THE LACK OF IRRIGATION. TO RESOLVE THE ISSUE, THE STAFF OBTAINED ANOTHER I/A SLEEVE FROM A STANDALONE SUPPLY IN ORDER TO COMPLETE I/Z WITH NO FURTHER ISSUES. THERE WAS NO HARM TO THE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60086 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON 0 IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INTREPID I/A TIP| 0.9 MM ULTRA KIT| THREADED HANDPIECE