Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1

FDA device recall Z-1455-2025 · posted 2025-03-26 · Open, Classified

Recall details

Recalling firm

CooperVision, Inc.

Reason for recall

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

Action taken

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

Root cause

Process control

Status

Open, Classified

Product code

MVN

Quantity affected

33990 lenses (17010 US, 16980 OUS)

Distribution

Domestic: CA, CO, FL, IL, KY, MI, NC, NE, NJ, NY, OH, OR, UT, VA, WA. International: Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Italy, Luxembourg, Netherlands, New

Date initiated

2025-02-27

Date posted

2025-03-26

Location

West Henrietta, NY

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