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

FDA device recall Z-3313-2024 · posted 2024-09-30 · Open, Classified

Recall details

Recalling firm

Alcon Research LLC

Reason for recall

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 taken

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 market.actions@alcon.com 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

Root cause

Process change control

Status

Open, Classified

Product code

LPL

Quantity affected

92,835 Packs

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,

Date initiated

2024-08-08

Date posted

2024-09-30

Location

Fort Worth, TX

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