BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 888853 · Received August 2, 2007

    Report

    Report Number
    2028159-2007-00375
    Event Type
    Injury
    Date Received
    August 2, 2007
    Date of Event
    July 3, 2007
    Report Date
    July 3, 2007
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. THIS REPORT MAILED IN TO FDA ON: 08/02/20007.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER RECEIVING AN ERROR CODE DURING PHACO, A POSTERIOR CHAMBER TEAR OCCURRED. THEY RESTARTED THE SYSTEM, PRIMED, TUNED, AND COMPLETED THE CASE. THEY STATED THERE WAS NO PATIENT INJURY. TWO CASES WERE CANCELLED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other| S