BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1061293 · Received June 13, 2008

    Report

    Report Number
    2028159-2008-00223
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 14, 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
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEWING THE AVAILABLE INSTRUMENT SETTING RECEIVED IN THE QUESTIONNAIRE, IT WAS CONCLUDED THAT THE SETTINGS DID NOT CONTRIBUTE TO THE PC TEAR. HOWEVER, WITH NO SAMPLES RECEIVED FOR FURTHER EVALUATION, THE ROOT CAUSE FOR THE REPORTED PC TEAR AND "MINIMAL ENERGY" FROM THE SYSTEM, IS UNK, AND CAN NOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE SYSTEM HAD MINIMAL ENERGY, CAUSING A POSTERIOR CAPSULE (PC) TEAR DURING A CASE. ADDITIONAL INFO RECEIVED STATED THAT THE PC TEAR OCCURRED DURING EPINUCLEUS REMOVAL, AND THERE WAS NO PHACO POWER. A VITRECTOMY WAS PERFORMED AND THE CASE WAS COMPLETED. HOWEVER, NO IOL WAS IMPLANTED, AND THE PT WILL REQUIRE A SECONDARY PROCEDURE TO IMPLANT THE IOL. THERE WAS NO FURTHER PT DATA, OR POST-OP INFO AVAILABLE.

    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