BEUDAMED
    FDA Recall Open, Classified

    Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

    Recall: Z-2412-2024 · Initiated May 23, 2024

    Recall

    Recall Number
    Z-2412-2024
    Event Number
    94848
    Firm
    Alcon Research LLC Aspex Facility
    FEI Number
    1610287
    Product Code
    FWJ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    May 23, 2024
    Posted
    July 18, 2024
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

    Reason

    After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.

    Action

    On 5/23/24, correction notices were mailed to customers informing them of the following: Prior to ending procedure, re-perform registration to ensure proper axis alignment. Firm is expediting a software update that is expected to be released to upgrade systems running on software version 1.5 starting mid-June 2024. Firm's Technical Service representative will contact you to schedule your service appointment for this software upgrade. If you choose to use the image guidance functionality for toric alignment, to mitigate the potential for this anomaly, users are advised to re-perform registration prior to ending the case or if any axis discrepancy is noted during the case. To re-perform registration, go to the registration step, re-confirm the reference image to the new surgery image, adjust the registration angle (if necessary), select "Confirm" and proceed to toric alignment or desired step. Complete and return the response form via email to [email protected] If you have any questions regarding this issue, please contact your Firm representative or Technical Support at 1-800-832-7827 or contact your local Sales Representative.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI, PR and the countries of Canada, Japan, France.

    Quantity

    230