BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3082497 · Received April 25, 2013

    Report

    Report Number
    2028159-2013-00772
    Event Type
    Injury
    Date Received
    April 25, 2013
    Report Date
    April 4, 2013
    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
    IL, 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED MULTIPLE PTS PRESENTED WITH TASS (TOXIC ANTERIOR SEGMENT SYNDROME) FOLLOWING CATARACT EXTRACTION PROCEDURE OVER THE PAST YEAR. THE SURGEON DOES NOT KNOW THE CAUSE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178195 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other OZIL TORSIONAL PHACO HANDPIECE| AMO IOL'S| DUOVISC| DISCOVISC| VISCOAT| HEALON GV