BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1833639 · Received September 8, 2010

    Report

    Report Number
    2028159-2010-01664
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 9, 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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND THE IV POLE FUNCTION WAS FINE. ALL THE SURGICAL MODES WERE TESTED AND WERE IN CORRECT OPERATION. A SYSTEM MESSAGE WAS FOUND IN THE EVENT LOG WHICH INDICATED AN OBSTRUCTION IN THE HANDPIECE OR TUBING. THE CUSTOMER IS DIRECTED TO CLEAN AND/OR REPLACE THE HANDPIECE OR TUBING BY THE SYSTEM MESSAGE. THE COMPANY SERVICE REPRESENTATIVE FOUND THE STAFF WAS MANUALLY LOWERING THE IV POLE TO REMOVE THE IRRIGATION BOTTLE, INSERT A NEW CASSETTE, SPIKE A NEW IRRIGATION BOTTLE AND PRIME THE SYSTEM. AFTER PRIMING IS COMPLETED THE IV POLE LOWERS TO THE PREVIOUS LEVEL USED AND NOT THE MEMORY SETTING. THE IV POLE ISSUE WAS DISCUSSED WITH THE CUSTOMER. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4)

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "POSTERIOR CAPSULE TEAR" (CAPSULE BAG TEAR, POSTERIOR). PRODUCT PROBLEM(S): "IV POLE CAME DOWN FROM 95 TO 35 ITSELF" (NO CODE AVAILABLE); "LOW ASPIRATION" (ASPIRATION ISSUE). THE NURSE REPORTED LOSS OF CONTROL OF THE I/V POLE AND ASPIRATION VACUUM. A POSTERIOR CAPSULE TEAR OCCURRED. ADD'L INFO RECEIVED FROM THE NURSE STATED THAT DURING SURGERY THERE WAS LOW TO NO ASPIRATION VACUUM. THE HANDPIECE WAS CHANGED AND THE SYSTEM WAS PRIMED AGAIN. THE IV POLE CAME DOWN FROM 95 TO 35 BY ITSELF AND THE PT SUFFERED A POSTERIOR CAPSULE TEAR AND LOSS OF VITREOUS. THE SURGERY WAS COMPLETED AND THE IOL WAS IMPLANTED. ADD'L INFO RECEIVED STATED, A CHAMBER COLLAPSE CONTRIBUTED TO THE POSTERIOR CAPSULE TEAR. THIS COMPLICATION WAS DUE TO A STRONG SURGE DURING SURGERY. THE IOL WAS IMPLANTED IN THE SULCUS. THE SURGERY WAS COMPLETED IN AN HOUR AND 22 MINUTES.

    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 84 YR Other MIOCHOL