BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYS

    MDR report key: 4240948 · Received November 5, 2014

    Report

    Report Number
    2028159-2014-02077
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PHACO TIP (UNSPECIFIED PRODUCT) WAS RETURNED FOR OCCLUSION AND A THERMAL INJURY. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT INFO WAS PROVIDED FOR A LOT RECORD REVIEW, THE ROOT CAUSE FOR CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CATARACT PROCEDURE, THERE WAS NO ASPIRATION. AFTER AN ULTRASOUND SHOT WAS PERFORMED, A BURN TO THE INCISION OCCURRED. THE PHACOEMULSIFICATION TIP WAS REPLACED AND THE SURGERY WAS COMPLETED. SUTURES WERE USED TO CLOSE THE INCISION. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709832 INFINITI VISION SYS PHACOFRAGMENTATION SYS HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R UNSPECIFIED PHACOEMULSIFICATION TIP