BEUDAMED
    FDA Recall Open, Classified

    Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

    Recall: Z-0326-2026 · Initiated September 30, 2025

    Recall

    Recall Number
    Z-0326-2026
    Event Number
    97739
    Firm
    Alcon Research LLC
    FEI Number
    1610287
    Product Code
    LPL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 30, 2025
    Posted
    October 24, 2025
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

    Reason

    Potential for a weak seal in some units resulting in compromise in sterility.

    Action

    Alcon notified consignees via letter on about 09/30/2025. Consignees were instructed to cease distribution of affected units to patients, review inventory to determine if affected units are on hand, dispose of all affected units, complete and return the response form, and forward the notification to other facilities or departments if product has been further distributed or transferred. For MARLO direct-to-patient shipments: As a part of our MARLO service, Alcon can notify patients who have received shipments directly from Alcon and initiate replacement on your behalf via the MARLO portal and app. You will receive a notification to opt in to this service in your ECP MARLO portal within the next week.

    Distribution

    Worldwide - US distribution in the states of Alabama, Arizona, Arkansas, Connecticut, Florida, Idaho, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oklahoma, Oregon, Tennessee, Texas, Washington and the country of Canada.

    Quantity

    82 units