BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1772253 · Received July 22, 2010

    Report

    Report Number
    2028159-2010-01260
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 20, 2010
    Report Date
    June 22, 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
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFORMATION BECOMES AVAILABLE. (B)(4)

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "HOLE ON THE BAG OF THE EYE: (CAPSULAR BAG TEAR, POSTERIOR); "ANTERIOR VITRECTOMY" (VITRECTOMY). PRODUCT PROBLEM(S): "IRRIGATION AND ASPIRATION FLOW DO NOT WORK" (ASPIRATION ISSUE); "IRRIGATION AND ASPIRATION FLOW DO NOT WORK" (INABILITY TO IRRIGATE). A SURGEON REPORTED THAT THE VITRECTOMY PROGRAM DID NOT WORK. THE PATIENT REQUIRED AN UNPLANNED ANTERIOR VITRECTOMY DUE TO A HOLE IN THE POSTERIOR CAPSULE WHEN THE LENS WAS REMOVED. IN ORDER TO PERFORM THE ANTERIOR VITRECTOMY, THE SURGEON AND THE NURSE CHOSE TO FOLLOW THE INSTRUCTIONS/SETUP ON THE SCREEN BUT IT DID NOT WORK. THE CUTTER WAS CUTTING. HOWEVER, NO WATER WAS COMING OUT THROUGH THE CANNULA AND NO ASPIRATION OF WATER THROUGH THE VITRECTOMY. PER SURGEON, THE INSTRUCTIONS WERE CORRECT AND IT WAS THE VITRECTOMY PROGRAM THAT WAS NOT WORKING WHEN THE INSTRUCTIONS WERE FOLLOWED. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THE SURGERY WAS 15-20 MINUTES DELAYED. THERE WERE NO PROBLEMS WITH THE PATIENT OR WITH THE PATIENT'S SIGHT.

    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 NI Required Intervention