BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2161829 · Received July 8, 2011

    Report

    Report Number
    2028159-2011-00794
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    May 4, 2011
    Report Date
    June 9, 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
    BE
    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING SECONDARY INTRAOCULAR LENS IMPLANTATION, THE PATIENT'S INTRAOCULAR PRESSURE (IOP) WAS NORMAL AT THE BEGINNING OF THE CASE, BUT THERE WAS A STRONG INCREASE WITH A STRONG VITREAL PRESSURE AT THE END AFTER IRRIGATION. A CAPSULAR RUPTURE OCCURRED AT IMPLANTATION, BUT WITHOUT REAL CONSEQUENCE AND A GOOD OPTICAL RESULT AFTERWARD. THE VISION IS OPTIMAL EVEN WITHOUT CORRECTION. THE IOP WAS NORMAL AGAIN THE NEXT DAY. THE SURGEON SUSPECTS, IT WAS A FORM OF MALIGNANT GLAUCOMA. THIS IS THE SECOND OF TWO RELATED REPORTS FOR THIS FACILITY.

    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 Required Intervention (B)(4) INTRAOCULAR LENS