BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3900056 · Received May 27, 2014

    Report

    Report Number
    2028159-2014-00972
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    November 20, 2013
    Report Date
    April 29, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT HAS BEEN PERFORMED AND A SAMPLE HAS BEEN RECEIVED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WIL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED A CORNEAL BURN AT THE INCISION SITE DURING A CATARACT SURGERY. THE PATIENT'S LEFT EYE (OS) WAS AFFECTED. THE PROCEDURE WAS COMPLETED AND THE INCISION WAS CLOSED WITH TWO SUTURES. THE PATIENT'S POSTOPERATIVE STATUS HAS NOT BEEN REPORTED AT THIS TIME. THE REPORTER INDICATED THAT DUE TO THE DYNAMICS OF THE OPERATING SESSIONS, IT WAS IMPOSSIBLE TO DETERMINE WHICH HANDPIECE WAS USED IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY INDICATED THAT THE DAY THEY CHANGED THE HANDPIECES, THEY DID NOT HAVE ANY FURTHER BURNS OR PROBLEMS DURING THE SURGERIES PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THIS IS THE TENTH OF THIRTEEN MEDICAL DEVICE REPORTS BEING FILED FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311932 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention OZIL TORSIONAL PHACO HANDPIECE