BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2113644 · Received June 1, 2011

    Report

    Report Number
    2028159-2011-00609
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SVC. NO SAMPLES WERE RETURNED FOR EVAL. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE (B)(6): PREVENTING CORNEAL BURNS DURING PHACOEMULSIFICATION, (B)(6), MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MALFUNCTIONING EQUIPMENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PT EXPERIENCED A SEVERE CORNEAL BURN DURING PHACOEMULSIFICATION. THE CONSOLE WAS REPORTED TO HAVE PRIME AND TUNED SUCCESSFULLY. UPON THE SURGEON MAKING THE INITIAL GROOVE, THE TIP WAS OBSERVED TO BE BLOCKED. THE OCCLUSION BELL DID NOT SOUND. THE WOUND REQUIRED FIVE SUTURES TO CLOSE. ADD'L INFO HAS BEEN REQUESTED.

    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 Required Intervention