BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2214088 · Received July 21, 2011

    Report

    Report Number
    2028159-2011-00843
    Event Type
    Other
    Date Received
    July 21, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 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
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. THE COMPLAINT SAMPLE HAS NOT YET BEEN RECEIVED FOR DECREASED TIP ASPIRATION AND VISCOELASTIC REMAINING IN THE EYE. PER THE CUSTOMER (B)(6), THE HANDPIECE WAS TESTED AFTER THE CASE AND IT WORKED NORMALLY AND ADDITIONAL SURGERIES WERE PERFORMED WITH THE HANDPIECE THE NEXT DAY WITH NO PROBLEM. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED DECREASED ASPIRATION WITH AN IRRIGATION/ASPIRATION (I/A) HANDPIECE DURING SURGERY. AFTER SURGERY, VISCOELASTIC WAS OBSERVED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE NURSE REPORTING THAT THIS ISSUE OCCURRED DURING IRRIGATION/ASPIRATION MODE. SHE STATED THE SURGEON INDICATED THAT ON THE PATIENT ONE-DAY POST-OPERATIVE EXAMINATION, VISCOELASTIC WAS OBSERVED IN THE ANTERIOR CHAMBER AND THE UNCORRECTED VISUAL ACUITY IN THE AFFECTED EYE WAS 20/200. THE NURSE FURTHER STATED THAT THE SURGEON MAY NEED TO PERFORM ADDITIONAL LASER TREATMENT BUT THAT REMAINS UNCONFIRMED AT THIS TIME.

    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 Other