BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INIFINITI VISION SYSTEM OZIL

    MDR report key: 2172672 · Received July 20, 2011

    Report

    Report Number
    2028159-2011-00839
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYS AND REPLACED THE FLUIDICS MODULE, THE DC POWER FLUID CABLE, AND THE POWER SUPPLY CABLE. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A CORNEAL BURN OCCURRED DURING SURGERY. ADD'L INFO WAS RECEIVED FROM THE SURGEON INDICATING THE EVENT OCCURRED DURING THE (B)(6). THE PT HAD A SUBCAPSULAR CATARACT WITH A SOFT NUCLEUS. THE SURGEON OBSERVED A SIGNIFICANT CORNEAL BURN WHEN HE WAS USING THE ULTRASONIC HANDPIECE TO SCULPT THE FIRST GROOVE. THE BURN WAS NOTED BEFORE THE GROOVE WAS COMPLETELY SCULPTED. THE SURGEON CHECKED HIS PARAMETERS BUT DID NOT FIND ANYTHING WRONG. THE SURGEON USED A SECOND HANDPIECE TO COMPLETE THE SURGERY. AFTER THAT, HE NOTED A VARIATION IN ANTERIOR CHAMBER DEPTH. THE SURGEON MENTIONED THAT THE SLEEVE WAS A LITTLE BIT SQUEEZED BY THE INCISION. INCISION SIZE WAS 2.4 MM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention