BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2822716 · Received November 2, 2012

    Report

    Report Number
    2028159-2012-01691
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    January 1, 2012
    Report Date
    October 3, 2012
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED BUT HAS NOT YET BEEN EVALUATED. 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 TECHNICIAN REPORTED A TRAILING HAPTIC AMPUTATION, DURING A CATARACT INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE SURGEON DID NOT NOTICE THAT THE HAPTIC WAS STILL TRAPPED AND WITHDREW THE HAND PIECE. THE SURGEON WAS ABLE TO IMPLANT A NEW IOL ON THE SAME DAY WITH NO PATIENT HARM.

    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 INTREPID AUTOSERT IOL INJECTOR