BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1191512 · Received September 26, 2008

    Report

    Report Number
    2028159-2008-00350
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Report Date
    August 27, 2008
    Manufacturer
    ALCON - IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSP NURSE MGR STATED THAT ALL SINGLE USE TIPS GET REUSED UNTIL THE SURGEON REQUESTS A NEW ONE. THE SURGEON WILL REQUEST A NEW TIP IF THE TIP IS NO LONGER SHARP. SHE WILL SEND IN A FEW AVAILABLE TIPS FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 09/26/2008.

    Description of Event or Problem · 1

    THE SURGEON REPORTED A SMALL METAL FRAGMENT 0.2MM IN SIZE WAS FOUND SITTING ON THE SURFACE OF THE IRIS AFTER PHACO SURGERY. THE SURGEON STATED THE EYE IS QUIET AT THE MOMENT AND THE PATIENT IS DOING WELL. THE SURGEON DECLINED TO PROVIDE ADDITIONAL INFO AND DEFERRED FURTHER QUESTIONS TO THE HOSP NURSE MGR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI