BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1040482 · Received May 9, 2008

    Report

    Report Number
    2028159-2008-00164
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECS. THE SYSTEM PARAMETERS USED BY THE CUSTOMER AT THE TIME THE REPORTED EVENT OCCURRED WERE REVIEWED; HOWEVER, THERE WERE NO ABNORMAL CONDITIONS NOTED DURING THIS REVIEW. A REVIEW OF COMPLAINTS FOR THE LAST 36 MOS DID NOT INDICATE ADVERSE TRENDS FOR THE REPORTED ISSUE ASSOCIATED WITH THE SYSTEM. A REVIEW OF THE SERVICE HISTORY FOR THIS SYSTEM DID NOT INDICATE ANY ADDITIONAL, RELATED REPORTS NOR DID IT INDICATE ADVERSE TRENDS FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD NOT ASPIRATE IN PHACO MODE. THE CUSTOMER STATED THE INCIDENT OCCURRED DURING SCULPTING. THE SYSTEM DID NOT DISPLAY ANY ERROR MESSAGES OR POP-UPS. NO OCCLUSION WAS BROKEN. THE CATARACT WAS "FLYING", WITH PARTICLES CAUSING THE ZONULE DEHISCENCE. THE CHAMBER INSTABILITY WAS REPORTED TO HAVE BEEN "CONTINUOUS, NEVER RECOVERED". THE SURGEON FINISHED THE CATARACT EXTRACTION MANUALLY. THE SURGEON WAS ABLE TO COMPLETE THE CASE, AND IMPLANTED AN IOL. THE PT HAD ZONULE DEHISCENCE AND EDEMA. THE PT OUTCOME IS NOTED AS GOOD. THE CUSTOMER SWITCHED OUT THE SYSTEM, AND COMPLETED THE REST OF THE CASES WITH NO FURTHER PROBLEMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S