BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINI SYSTEM

    MDR report key: 4620781 · Received February 13, 2015

    Report

    Report Number
    3006247712-2015-00001
    Event Type
    Injury
    Date Received
    February 13, 2015
    Date of Event
    January 10, 2015
    Report Date
    February 12, 2015
    Manufacturer
    LUTRONIC CORP,
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REPORTED ON (B)(6) 2015 THAT HE TREATED A PATIENT ON (B)(6) 2015, WHO IMMEDIATELY FOLLOWING THE INFINI TREATMENT, COMPLAINED OF SEVERE EYE PAIN. THE PHYSICIAN TREATED THE PATIENT NEAR THE EYES. ACCORDING TO THE PHYSICIAN THE PATIENT REPORTED TO HIM 3 DAYS AFTER THE TREATMENT THAT HE HAD EXPERIENCED CORNEAL BURN. THE PHYSICIAN COMMUNICATED VERBALLY THAT THE PATIENT WHO WAS UNDER THE CARE OF AN OPHTHALMOLOGIST. ON (B)(6) 2015, LUTRONIC GLOBAL CLINICAL SCIENCE OFFICER SPOKE WITH THE PHYSICIAN VIA PHONE AND REQUESTED THE PHYSICIAN TO FILL OUT THE LUTRONIC ADVERSE COMPLAINT HANDLING FORM TO DETAIL THE TREATMENT AND PATIENT CONDITION. THE LUTRONIC ADVERSE COMPLAINT HANDLING FORM WAS SENT VIA EMAIL TO THE PHYSICIAN IMMEDIATELY FOLLOWING THE TELEPHONE CALL ON (B)(6) 2015. AN EMAIL ON (B)(6) 2015 BY THE (B)(6) OFFICER REMINDED THE PHYSICIAN TO COMPLETE THE FORM. SUBSEQUENTLY 2 PHONE CALLS ON (B)(6)2015 AND ONE PHONE CALL ON (B)(6)2015 WERE SENT FROM THE (B)(6) OFFICER TO THE PHYSICIAN. THE PHYSICIAN HAS NOT COMPLETED THE LUTRONIC ADVERSE COMPLAINT HANDLING FORM AND LUTRONIC DOES NOT YET KNOW THE DETAILS OF THE INCIDENT OR THE CONDITION OF THE PATIENT. ON (B)(6)2015 THE PHYSICIAN VERBALLY INFORMED A LUTRONIC REP THAT THE PATIENT WAS COMFORTABLE AND SOME SIGHT LOSS HAS NOT RESOLVED. ON (B)(6) 2015 THE INFINI SYSTEM WAS REMOVED FROM THE PHYSICIAN'S OFFICE. ON (B)(6) 2015 THE LUTRONIC SYSTEM ENGINEER ASCERTAINED THE SYSTEM WAS OPERATING WITHIN ALL SPECS AND WAS IN GOOD CONDITION. LUTRONIC REVIEWED THE ADVERSE EVENT AND HAS COME TO THE CONCLUSION THAT THE PHYSICIAN DID NOT USE OCULAR EYE SHIELD WHILE TREATING AROUND THE EYE AND THAT THIS IS IN ALL PROBABILITY OPERATOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106937 INFINI SYSTEM NI GEI LUTRONIC CORP,

    Patients

    Seq Age Sex Outcome Treatment
    1 Other