BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3760790 · Received April 7, 2014

    Report

    Report Number
    2028159-2014-00537
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FIELD AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING THE PHACOEMULSIFICATION PART OF THE CATARACT WITH LENS IMPLANT PROCEDURE; MOST OF THE CORTEX WAS REMOVED. VISCOELASTIC WITH INJECTED AND THE INTRAOCULAR LENS (IOL) WAS PLACED IN THE BAG. THE SURGEON REMOVED THE REMAINING VISCOELASTIC AND ATTEMPTED TO REMOVE THE REMAINING CORTEX, WHICH WAS BEHIND THE IOL. THE IOL WAS PUSHED AWAY FROM THE WOUND, AND THEN PULLED FORWARD IN AN EFFORT TO LOOSEN THE CORTEX FROM THE POSTERIOR CAPSULE. THE LENS THEN MOVED ITSELF BACK AWAY FROM THE WOUND. THE SURGEON USED IRRIGATION/ASPIRATION AND CAPTURED AN AREA OF THE POSTERIOR CAPSULE. THE CAPSULE DID NOT TEAR, HOWEVER, THE ZONULES WERE WEAKENED AND VITREOUS SEEPED FORWARD AROUND THE INTACT CAPSULE BAG. AN ADDITIONAL PARACENTESIS WAS CREATED, AND ANTERIOR VITRECTOMY WAS PERFORMED. A SECOND PARACENTESIS WAS MADE TO AID IN THE VITRECTOMY. THE SURGEON PLANNED TO LEAVE THE IOL IN THE BAG. CARBACHOL WAS USED TO SHRINK THE PUPIL. A SECOND INSTRUMENT WAS INTRODUCED TO RETRACT THE IRIS TO VIEW THE EDGE OF THE CAPSULORHEXIS. AT THAT POINT, IT BECAME NOTICEABLE THAT A LARGER AREA OF ZONULES, APPROXIMATELY FOUR CLOCK HOURS WERE WEAKENED. IT WAS DECIDED TO REMOVE THE IOL AND EXCHANGE IT FOR A THREE PIECE SULCUS LENS. THE FIRST IOL WAS FOLDED INSIDE THE EYE AND REMOVED THROUGH THE ORIGINAL INCISION WITHOUT ENLARGING IT. A THREE PIECE SULCUS LENS WAS INSERTED. THREE SUTURES WERE USED, ONE FOR EACH INCISION. THE PT IS EXPECTED TO HAVE NO CONSEQUENCE FROM THE EVENTS. ADDITIONAL INFO PROVIDED STATES THAT AT ONE DAY POST-OP THE PT EXPERIENCED CORNEAL EDEMA AND STROMAL AND ENDOTHELIAL WRINKLES. THE SURGEON FEELS THE EDEMA AND WRINKLES ARE A RESULT OF THE ADDITIONAL MANIPULATION OF THE EYE DURING THE INITIAL PROCEDURE. THE PUPIL IS ROUND AND THERE IS NO SIGN OF VITREOUS IN AN ANTERIOR CHAMBER. THE PT REPORTS THAT THE EYE IS COMFORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205703 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention