BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 4840159 · Received June 12, 2015

    Report

    Report Number
    2028159-2015-06443
    Event Type
    Injury
    Date Received
    June 12, 2015
    Report Date
    July 10, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K120912
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: EVALUATION SUMMARY: NO PHACO TIP WAS RETURNED FOR A CORNEAL BURN USING THE SYSTEM. CUSTOMER BELIEVES THE FLARED DESIGN OF THIS PHACO TIP HAS A PROBLEM WITH CLOGGING WHEN USING THE SPECIFIC MODE WITH THE MACHINE SYSTEM. A DEVICE HISTORY RECORD REVIEW FOR THE LOT WAS CONDUCTED. NO ANOMALIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE PRODUCT WAS RELEASED BASED ON MANUFACTURER¿S ACCEPTANCE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED AND THE LOT INFORMATION INDICATES THE PRODUCT WAS RELEASED BASED ON MANUFACTURER¿S ACCEPTANCE CRITERIA, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION WITH NO RESPONSE TO DATE. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR OF OPHTHALMOLOGY REPORTED PHACOBURN EPISODES DURING SEVERAL SURGERIES WHILE USING THE SYSTEM WITH THE FLARED TIPS. NO SUTURES WERE NEEDED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION WITH NO RESPONSE TO DATE. THIS IS ONE OF THREE REPORTS BEING FILED FOR THE SAME EVENT. THIS REPORT IS FOR THE POOL OF PATIENTS WITH NO SUTURE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385616 INFINITI VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TURBOSONIC MINIFLARED ABS PHACO TIP 45 OZIL 12,0.9