BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1063487 · Received June 20, 2008

    Report

    Report Number
    2028159-2008-00230
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ALCON - IRVINE TECHOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP HAD CHECKED THE SYSTEM IN APRIL AND FOUND THE SYSTEM MET ALL PRODUCT SPECIFICATIONS. THE CUSTOMER STATED THE SYSTEM WAS USED BY ANOTHER SURGEON AFTER THIS EVENT AND NO PROBLEMS NOTED. THE INCISION WAS 2.2MM WITH A 0.9MM 45 KELMAN DEGREE TIP USED. THIS INCISION SIZE IS RECOMMENDED FOR THIS TIP PER THE DIRECTIONS FOR USE. SERVICE WAS NOT REQUESTED AFTER THIS EVENT REPORTED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING PHACOEMULSIFICATION A THERMAL INJURY OCCURED. THE INCISION WAS 2.2MM WITH A 0.9MM 45 KELMAN DEGREE TIP USED. THE EVENT OCCURRED DURING SCULPTING. THERE WAS A TIGHTNESS NOTED AT THE CORNEAL INCISION AFTER THE THERMAL INJURY. THE WOUND WAS CLOSED WITH 10-0 NYLON SUTURES WITH ASTIGMATISM NOTED. THE CUSTOMER STATED THE OUTCOME OF THE EVENT WAS POOR AND THE PROGNOSIS OF THE PT IS GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R