BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2192455 · Received July 27, 2011

    Report

    Report Number
    2028159-2011-00869
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY TECHNICAL SUPPORT SPECIALIST (TSS) TO ASSIST WITH TROUBLESHOOTING THE SYSTEM. THE TSS RECOMMENDED REBOOTING. THE CUSTOMER ATTEMPTED TO REBOOT WITH NO DISPLAY NOTED. THE CUSTOMER CANCELLED THE CALL AS IT WAS REPORTED THE FACILITY BIOMEDICAL TECH REPLACED THE HOST POWER DISTRIBUTION PRINTED CIRCUIT BOARD (PCB) AND THE SYSTEM WAS WORKING. THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING A CATARACT SURGERY, THE SYSTEM FROZE. AFTER A LONG DELAY, IT WAS DETERMINED THAT THE CASE COULD NOT BE COMPLETED AND THE INTRAOCULAR LENS WAS NOT IMPLANTED. THE PT WAS SENT TO ANOTHER FACILITY, ON THE FOLLOWING DAY, TO COMPLETE THE PROCEDURE. THERE WAS NO PT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention