BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3190753 · Received June 24, 2013

    Report

    Report Number
    2028159-2013-01124
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND WAS NOT ABLE TO REPLICATE THE REPORTED EVENT. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF THE SYSTEM'S EVENT LOG FOR THE DATE OF (B)(4) 2013 DID NOT REVEAL ANY NONCONFORMITY RELATED TO THE ASPIRATION; THE EVENT LOG SHOWED NO ABNORMAL ACTIVITY. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A NURSE MANAGER REPORTED THAT ASPIRATION WAS LOW DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE PROCEDURE TOOK AN ADDITIONAL THREE MINUTES TO COMPLETE, AND WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286051 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1