BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2630827 · Received June 22, 2012

    Report

    Report Number
    2028159-2012-00921
    Event Type
    Injury
    Date Received
    June 22, 2012
    Date of Event
    May 15, 2012
    Report Date
    May 24, 2012
    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
    MI, 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CLINICAL COORDINATOR REPORTED TWO CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE SITE COULD NOT IDENTIFY THE PROBABLE CAUSE OF THE TASS SO A LIST OF THE SURGICAL PRODUCTS USED WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL COORDINATOR INDICATING THAT THERE HAVE BEEN NO ADDITIONAL CASES OF TASS SINCE THEY SWITCHED TO DISPOSABLE BLADES. THIS REPORT REPRESENTS THE FIRST OF TWO CASES OF TASS REPORTED FROM THIS FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other MONARCH III "D" CARTRIDGES| SN60WF| OZIL TORSIONAL PHACO HANDPIECE| SINGLE USE ANGLED I/A TIP| BSS PLUS| POLYMER TIPS| DIAMOND KNIFE| SURGICAL KNIFE| DUOVISC