BEUDAMED
    FDA Recall Open, Classified

    DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,

    Recall: Z-3313-2024 · Initiated August 8, 2024

    Recall

    Recall Number
    Z-3313-2024
    Event Number
    95249
    Firm
    Alcon Research LLC
    FEI Number
    1610287
    Product Code
    LPL
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    August 8, 2024
    Posted
    September 30, 2024
    Address
    6201 South Fwy Aspex Facility Fort, Worth, TX, 76134-2099

    Description

    DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,

    Reason

    Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision.

    Action

    On 8/8/24, recall notices were sent to customers who were asked to do the following: 1) Discontinue any further distribution of affected product. 2) Dispose of all affected product. If immediate destruction is not feasible, ensure the identified lots are segregated from unaffected products. 3) Forward this notification to departments within your organization who may be in possession of the affected product. 4) Contact other organizations, eye care providers and/or individuals to whom you have transferred or distributed the identified lots, and patients, and inform them of this Voluntary Medical Device Recall, and request they dispose of contact lenses from the identified lots. For your convenience, a notification template is enclosed for communicating this issue to your customers/patients. 3) Complete and return the response form via email to [email protected] Alternately, respond via QR code: myalcon.com/notification-response-form If you have questions about the notice, or replacement process, or need electronic copies of the notification letter, call 1-888-266-7974

    Distribution

    US: UT, TX, NC, MT, AL, WA, MS, PA, LA, MI, GA, FL, KY, OH, AZ, IL, CA, NJ, TN, NY, AR, MN, WI, MD, OK, SC, OR, MA, CO, VA, CT, IA, DE, WV, MO, ID, SD, NE, NV, IN, ME, VT, NM, NH, AK, HI, KS, RI, WY, PR, DC. OUS: GB, NL, HK, ES, PL, IT, FR, CA, CH, PT, AT, DE, NO, GG, LU, CZ, SK, DK, FI, SE, IN, OM, BE, QA, KW, SA, AE, LB, BH, HU, MY, IE, SG, IS, XI, MK, GI, MT, KR, SI, NZ, GR, GF, GP, MQ, TW, EE, GL, GE, IL, UA, FO, LV, AD, RS, LT, RO, SM, AZ, AU, JE, HR, AX, LI, CY, BG

    Quantity

    92,835 Packs