BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1013822 · Received March 14, 2008

    Report

    Report Number
    2028159-2008-00100
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 9, 2008
    Report Date
    February 13, 2008
    Manufacturer
    ALCON - IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE ECRI HEALTH DEVICES, HAZARD UPDATE: SCLERAL AND CORNEAL BURNS DURING PHACOEMULSIFICATION, NOV 1996, VOL. 25, NO. 11: 426-431, MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MALFUNCTIONING EQUIPMENT. A LETTER AND COPY OF THIS INDUSTRY ARTICLE WAS PROVIDED TO THE CUSTOMER. A COPY OF THE DIRECTIONS FOR USE (DFU) FOR THE HANDPIECE WAS ALSO PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PHACOEMULSIFICATION, THE CATARACT COULD NOT BE REMOVED, AND THE REMAINDER OF THE NUCLEUS WAS REMOVED BY FORCEPS THROUGH THE MAIN INCISION. ON DAY POST OPERATIVELY THE PATIENT PRESENTED WITH A CORNEAL BURN AT THE MAIN INCISION. THE EYE TISSUE WAS PALE AND CORNEAL BLISTERS APPEARED. THE PATIENTS EYE WAS HEAVILY (SIC) BURNED, SWOLLEN, WITH THE DESCEMET'S MEMBRANE FOLDING. THE CUSTOMER NOTED THIS CONDITION WILL REQUIRE LONG TERM TREATMENT. THE SURGEON STATED THE PERMANENT INJURY OF THE CORNEA MAY RESULT DUE TO THE CORNEAL BLISTER DEGENERATION. PATIENT OUTCOME IS UNK. ADD'L INFO RECEIVED STATED THIS WAS THE THIRD SURGERY OF THE DAY. DURING SURGERY, THE SYSTEM WOULD NOT PHACO WITH AN ERROR MESSAGE NOTED WHICH INDICATED AN ADVISORY OF FLOW OBSTRUCTION, PLEASE CHECK HANDPIECE FREE FLOW. THIS REPORT IS FOR ONE PATIENT; FOR ADD'L PATIENTS, SEE MFG REPORT #'S: MDR 2028159-2008-00101 AND MDR 2028159-2008-00102.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IOL SA60AT| PROVISC| RAYVISC| BSS| SUBCONJUNCTIVAL INJECTION OF DEXAVEN & LINCOCIN