BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1243146 · Received November 21, 2008

    Report

    Report Number
    2028159-2008-00420
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 23, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM HAD SCHEDULED PREVENTATIVE MAINTENANCE COMPLETED THE WEEK PRIOR TO THE EVENT. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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. THIS REPORT WAS MAILED TO FDA ON: 11/21/2008.

    Description of Event or Problem · 1

    THE SURGEON REPORTED A CORNEAL BURN OCCURRED WITHIN MICRO SECONDS OF PHACO. ADDITIONAL INFORMATION RECEIVED STATED THE CORNEAL BURN IS ON THE RIGHT SUPERIOR EDGE OF THE WOUND. NO WOUND LEAKAGE WAS DETECTED AT THE END OF SURGERY AND THE FIRST POST OPERATIVE DAY. HOWEVER, THE IOP WAS 01MMHG WITH SEIDEL NEGATIVE AND RETINAL FOLDS NOTED. THE PATIENT WAS SEEN THE SECOND POST OPERATIVE DAY WITH SEIDEL POSITIVE AND RETINAL FOLDS PRESENT. THE WOUND WAS SUTURED AND THE VISUAL ACTIVITY WAS 20/40 WITH THE IOP AT 12MMHG AND NO RETINAL FOLDS PRESENT. THE PATIENT OUTCOME AND PROGNOSIS IS GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention BSS| PRO VISC| NEVANAC| KETOROLAC