BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3231489 · Received July 15, 2013

    Report

    Report Number
    2028159-2013-01399
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THE DIRECTOR OF NURSING REPORTED FOUR CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURES. ALL FOUR PATIENTS WERE TREATED WITH INTENSIVE ANTI-INFLAMMATORY THERAPY WITH NO CHRONIC COMPLICATIONS. ALL FOUR PATIENTS SYMPTOMS HAVE RESOLVED. THIS IS THE THIRD OF FOUR REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327640 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OZIL TORSIONAL HANDPIECE| INT PLUS BASIC PAK| ACRYSOF INTRAOCULAR LENS (IOL) (B)(4)| BALANCED SALT SOLUTION (BSS)| DUOVISC| MONARCH D CARTRIDGE| CUSTOM PAK