BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINIT VISION SYSTEM OZIL

    MDR report key: 4132664 · Received September 24, 2014

    Report

    Report Number
    2028159-2014-01769
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT TWO DAYS AFTER UNDERGOING AN UNEVENTFUL PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A DISTURBANCE IN THE LEFT EYE AND SOUGHT EMERGENCY SERVICE. THE PATIENT PRESENTED WITH CORNEAL EDEMA, CORNEAL INFILTRATES, ELEVATED INTRAOCULAR PRESSURE, HYPOPYON, VITRITIS. THE PATIENT WAS REFERRED TO ANOTHER HOSPITAL, AND WAS DIAGNOSED WITH ENDOPHTHALMITIS. EYE CULTURES WERE PERFORMED AND INTRAVITREAL ANTIBIOTIC TREATMENT WAS STARTED. A VITRECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2014. THE PATIENT WAS REPORTED TO HAVE A POOR VISUAL PROGNOSIS (FROM VISUAL IMPAIRMENT TO UNILATERAL BLINDNESS). THE PATIENT IS CONTINUING TO RECEIVE ANTIBIOTIC TREATMENT. THE REPORTER DID NOT KNOW WHAT CAUSED THE ENDOPHTHALMITIS. IT WAS NOTED THAT THE SINGLE I/A (IRRIGATION/ASPIRATION) TIP HAD MORE THAN ONE YEAR OF USE. THIS IS THE SECOND OF TWO REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595670 INFINIT VISION SYSTEM OZIL PHACOFRAGMENTATIO SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention 45KT| VIAGAMOX| SN60WF ACRYSOF SP NATURAL IQ LENS| ZYMAR| A (IRRIGATION/ASPIRATION) TIP| INFINITI PHACO HANDPIECE| MONARCH III "D" CARTRIDGE| IOL INJECTOR| NEVANAC| TS TIP| SIMCOE CANNULA| MINI FLAIR AB 0.9MM| INTREPID PLUS PAK 0.9MM ULTRA| DUOVISC| BSS (BALANCED SALT SOLUTION)| ANESTALCON| PRED FORTE| MIOSTAT| A-OK 15D FULL HANDLE 1.52MM| EYE-PAK DRAP BLUE NW FABRIC