BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 4780149 · Received May 19, 2015

    Report

    Report Number
    2028159-2015-06063
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 22, 2015
    Report Date
    September 14, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K120912
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FOR THIS COMPLAINT FILE, THE FINAL CUSTOMER LOT WAS IDENTIFIED AND FOUR PHACO TIP COMPONENT LOTS WERE USED TO MAKE UP THE FINAL LOT. A DEVICE HISTORY RECORD REVIEW FOR THE LOTS WAS CONDUCTED. NO ANOMALIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEWS. THE PRODUCT WAS RELEASED BASED ON MANUFACTURER ACCEPTANCE CRITERIA. NO ADDITIONAL INVESTIGATION IS REQUIRED BASED ON DEVICE HISTORY REVIEWS. BECAUSE A SAMPLE WAS NOT RETURNED AND THE LOT INFORMATION INDICATES THE PRODUCT WAS RELEASED BASED ON MANUFACTURER 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE PHACO TIP WAS RETURNED FOR NOT BEING ABLE TO DIG IN THE EYE LENS. THE PHACO TIP WAS VISUALLY INSPECTED USING 30X MAGNIFICATION. THE PHACO TIP WAS DEEMED VISUALLY CONFORMING. THE BEVEL CUTTING EDGES WERE IN GOOD CONDITION AND IT WAS A 30 DEGREE BEVEL WITH A DETERMINED BEND CONFIGURATION. THE TIP WAS CHECKED FOR OCCLUSION AND NO BLOCKAGE WAS PRESENT. THE COMPLAINT DID NOT CONFIRM THE PHACO TIP WAS THE CAUSE OF THE POOR PERFORMANCE IN DIGGING THE LENS. THE PHACO TIP WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE MOST PROBABLE CAUSE FOR THE TIP NOT BEING ABLE TO DIG THE EYE LENS WAS FROM A POOR CONNECTION ONTO THE HANDPIECE, NO ULTRASONIC POWER FROM THE HANDPIECE, OR AN INCORRECT MACHINE SETTING.

    Description of Event or Problem · 1

    A PHARMACIST REPORTED A TIP DID NOT DIG IN THE EYE LENS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325388 INFINITI VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other