BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1030846 · Received April 17, 2008

    Report

    Report Number
    2028159-2008-00138
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    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
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE EXCESSIVE FLUID FLOW. THE FOOTSWITCH WAS REPLACED FOR DIAGNOSTIC PURPOSES. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECS. THE FOOTSWITCH WAS RECEIVED FOR IN-HOUSE TESTING. THE FOOTSWITCH PASSED ALL TESTING AND MET ALL PRODUCT SPECS. THE ROOT CAUSE OF THE REPORTED ISSUE OF EXCESSIVE FLUID FLOW DURING PHACOEMULSIFICATION WAS UNABLE TO BE DETERMINED. THERE WERE NO ADDITIONAL COMPLAINTS FOR THE SYSTEM OR FOR THE FOOTSWITCH. THERE WERE NO ADDITIONAL SERVICE REQUESTS OPENED FOR THIS SYSTEM RELATED TO THE REPORTED EVENT. A REVIEW OF COMPLAINT TRENDS INDICATES NO ADVERSE TRENDS FOR THE REPORTED COMPLAINT FOR THE LAST 36 MOS. A REVIEW OF SERVICE DATA INDICATED NO ADVERSE TRENDS FOR THE LAST 36 MOS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THERE WAS EXCESSIVE FLUID FLOW DURING PHACOEMULSIFICATION. THIS WAS THE SECOND CASE AND THE EVENT OCCURRED DURING QUADRANT REMOVAL OF THE CATARACT. DURING THE SURGERY, A "CHUNK OF NUCLEUS" FELL TO THE BACK OF THE EYE, CAUSING POSTERIOR CAPSULE TEAR. THERE WAS NO OCCLUSION THAT WAS BROKEN AND THE OCCLUSION BELL DID NOT GO OFF. THEY WERE ABLE TO COMPLETE THE SURGERY WITH THE BACK UP MACHINE. THE SURGEON PERFORMED AN ANTERIOR VITRECTOMY. THE ANTERIOR VITRECTOMY EXTENDED THE CASE BY 45 MINS. THE SURGEON STATED THE FOOTSWITCH WAS THE CAUSE OF THE REPORTED EVENT.

    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 Required Intervention| S