MyDay Toric Contact Lenses (CooperVision) – Incorrect Cylinder Power (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

a limited number of lots were manufactured with an incorrect cylinder power.

Recommended Action

Per FDA guidance

On February 27, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to direct consignees. We request you take the following actions: 1. Please examine your inventory/product shelf for any of the provided affected lot numbers. The lot number can be found on the back panel of the carton below the expiration date. (Carton lots 19346502595028, 19346502613028, 21545502813013, and 21512501331524) 2. While trials lenses are not impacted by this action, if your patients have discarded the carton, the affected product can be identified by examining the lot number printed on the blister. This number is different from the carton lot number. (Blister lots 6461501582, 6461501590, 6448502235, 6472500679) The lot number can be found on the front of the blister label below the expiration date. Below is an example and where to locate the lot number on both a carton and blister. Stop any further distribution of product from the designated lot numbers; 3. We recommend authorized distributors contact your accounts and Eye Care Practitioners contact your patients who have received the affected product with the enclosed draft Consumer Communication Letter, to be completed by the Eye Care Practitioner s office. 4. Please instruct any patients to return any affected product to their Eye Care Practitioner for replacement or credit. 5. Within the next five (5) business days, please complete the attached Correction Response Form and fax it to 888-385-3217 or scan and email to: info@coopervision.com. If you have no lenses from these specified lots, please put 0 in Quantity ; 6. Dispose of the affected product in your inventory or that is returned to you. 7. Your account will be credited once the form is received. 8. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting Program, either online, by regular mail, or by fax. 9. If your patients have questions or complaints, please have them contact our cu

Distribution

As reported by FDA

CA, CO, FL, IL, KY, MI, NE, NJ, NY, NC, OH, OR, UT, VA, WA