BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1013823 · Received March 14, 2008

    Report

    Report Number
    2028159-2008-00101
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 9, 2008
    Report Date
    February 13, 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
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYS WAS EXAMINED BY THE COMPANY SVC REP. THE COMPANY SVC REP COULD NOT DUPLICATE THE PROBLEM. THE SYS WAS TESTED AND MET ALL PROD SPECS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. 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, NOVEMBER 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 SEVERAL CORNEAL BURNS. THE NURSE CHANGED THE TIP AND CASSETTE SEVERAL TIMES, FLUSHED THE HANDPIECE UNDER PRESSURE, AND CHECKED FOR OCCLUSION. THE CASE WAS NOT COMPLETED AS PLANNED AND FORCEPS WERE NEEDED TO REMOVE SCRAPS OF NUCLEUS. THE PT HAD CORNEAL CLOUDING WITH BLISTERS AND DESCEMENT MEMBRANE FOLDING. THERE WERE SUBSEQUENT CASES CANCELED. ADD'L INFO REC'D STATED THE PT STATUS IS GOOD. THIS REPORT IS FOR ONE PT; FOR ADD'L PTS SEE MFG REPORT #S: MDR 2028159-2008-00100, 00102.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OPTHALMIC SURGERY SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

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