BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2070131 · Received April 22, 2011

    Report

    Report Number
    2028159-2011-00419
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 23, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYS AND COULD NOT DUPLICATE THE PROBLEM REPORTED. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO SAMPLE HAS BEEN RETURNED. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO INVESTIGATE THE REPORTED ISSUE. 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 NURSE REPORTED THAT DURING CATARACT EXTRACTION, THE NEED TO DO A VITRECTOMY AROSE. AS THEY WERE SETTING THE PARAMETERS FOR VITRECTOMY, THE ASPIRATION WOULD NOT WORK. TWO HANDPIECES WERE TRIED AND THE ASPIRATION STILL WOULD NOT FUNCTION. THE CATARACT WAS REMOVED, BUT AN IOL WAS NOT IMPLANTED. THE PT WILL REQUIRE AN ADDITIONAL SURGERY, BUT IT HAS NOT BEEN SCHEDULED AS YET. ADDITIONAL INFO HAS BEEN REQUESTED.

    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