BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2620756 · Received June 8, 2012

    Report

    Report Number
    2028159-2012-00850
    Event Type
    Injury
    Date Received
    June 8, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 10, 2012
    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
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REQUEST SERVICE TO CHECK THE SYSTEM, NOR DID THEY SEND IN SAMPLES FOR EVAL. NO FURTHER INFO HAS BEEN RECEIVED. ONE (1) LOT NUMBER FOR THE PHACO TIP AND ONE (1) LOT NUMBER FOR THE I/A (IRRIGATION/ASPIRATION) TIP WERE IDENTIFIED WITH THIS COMPLAINT. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER PROBLEM WERE FOUND DURING THE DEVICE HISTORY REVIEWS. NO LOT NUMBER WAS PROVIDED FOR THE I/A HANDPIECE AND NO SERIAL NUMBER WAS PROVIDED FOR THE PHACO HANDPIECE. THEREFORE, MFG INFO COULD NOT BE OBTAINED FOR THE I/A OR PHACO HANDPIECES. A SITE VISIT WAS CONDUCTED BY A COMPANY RECOMMENDED CONSULTANT. THE CONSULTANT OBSERVED PRE-SURGICAL SET UP, SURGERY, AND POST-SURGICAL CLEANING PROCESSES. DETAILED WRITTEN RECOMMENDATIONS WERE PROVIDED TO THE SITE. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PT WAS DIAGNOSED WITH TASS (TOXIC ANTERIOR SEGMENT SYNDROME) FOLLOWING CATARACT SURGERY. THE NURSE NOTES THAT THERE HAVE BEEN NO NEW ADDITIONAL CASES OF TASS SINCE A SITE VISIT BY A COMPANY RECOMMENDED CONSULTANT. ADDITIONAL 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 Other I/A STRAIGHT SILICONE TIP| I/A THREADED HANDPIECE| CUSTOM PAK| OZIL TORSIONAL PHACO HANDPIECE