BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2032387 · Received March 25, 2011

    Report

    Report Number
    2028159-2011-00285
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 24, 2011
    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
    MA, US
    Reporter Occupation
    OTHER

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A DIRECTOR OF NURSE REPORTED THAT WHILE THE SURGEON WAS REMOVING A PHACO TIP FROM A PT'S EYE, THE CAPSULE "SHALLOWED." THE SURGEON REPORTEDLY INJECTED THE CAPSULE WITH BSS. UPON REMOVING THE TIP FROM THE EYE, IT WAS NOTED THE TIP HAD A BURR WHICH HAD TORN THE CAPSULE. THIS RESULTED IN A DIFFERENT LENS BEING IMPLANTED AND SUBSEQUENTLY A LARGER INCISION SITE WITH SUTURES. THE PT'S CURRENT STATUS WAS STATED AS PRESENTING WITH ENDOPHTHALMITIS WHICH THE SURGEON ATTRIBUTES TO THIS EVENT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention