BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3181422 · Received June 14, 2013

    Report

    Report Number
    2028159-2013-01149
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 21, 2013
    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
    JA
    Reporter Occupation
    PHYSICIAN

    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED CORNEAL OPACITY DURING THE PHACO PORTION OF A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE PUPIL WAS DILATED WITH VISCOELASTIC BECAUSE THE PT HAD SYNECHIA AND POOR MYDRIASIS. VISCOELASTIC WAS ALSO USED TO DETACH ITS ADHESIONS. THE SURGEON TRIED TO EXTEND THE PUPIL SINCE THE PT USED ANTICOAGULANT MEDICATION. THE PT EXPERIENCED AN IRIS PROLAPSE DURING HYDRODISSECTION. THE IRIS WAS PUSHED INTO THE ANTERIOR CHAMBER WITH VISCOELASTIC. THE ULTRASOUND TIP (US) WAS DIFFICULT TO INSERT DUE TO MIOSIS. THE SURGEON TRIED TO INSERT THE US TIP INTO THE ANTERIOR CHAMBER; HOWEVER, THE IRIS PROLAPSE OCCURRED AGAIN. THE IRIS WAS PUSHED INTO THE ANTERIOR AGAIN WITH VISCOELASTIC. THE ANTERIOR CHAMBER WAS FILLED WITH VISCOELASTIC TO PREVENT IRI PROLAPSE AND THE SURGEON INJECTED US TIP AGAIN. AFTER STARTING TO "DIG" THE LENS WITH SCULPT MODE, THE SURGEON REPORTED THAT A SUBSTANCE DISCHARGED FROM THE US TIP AND IT WAS CLOGGED. THE US TIP WAS EXCHANGED, BUT A LARGE AMOUNT OF SUBSTANCE WAS DISCHARGED FROM THE US TIP AGAIN, THEN A THERMAL BURN OCCURRED AT THE INCISION. THE CORNEAL CLOUDING FROM THE BURN SPREAD TO CENTER OF CORNEA AND THE PROCEDURE WAS ABORTED. THE US TIP WAS PULLED OUT AND CORNEAL FOLD WAS OBSERVED. THE INCISION WAS CLOSED BY SEVERAL SUTURES. THE PT WAS MOVED TO ANOTHER HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270715 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INTINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R HEALON V