Recall Z-3248-2026

CooperVision, Inc. · initiated August 12, 2026

Open, Classified

Product

Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day

Codes / lots: Pearle Vision 1 day; Carton Lot # 11727620152030; Blister Lot # CB132348;

Reason for recall

A small number of lenses within the affected lot are of the incorrect power.

FDA-determined cause: Process control

Action taken

On August 24, 2026 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Please stop any further distribution of products from the designated lot number. 2. Dispose of the affected product in your inventory or that is returned to you. 3. Within the next five (5) business days, please complete the response form provided and return it. If you have no lenses from these specified lots, please put 0 in Quantity and return the form. 4. We recommend authorized distributors contact your accounts, and Eye Care Practitioners contact your patients who have received the affected product, with the enclosed Customer Communication Letter . 5. Please instruct any patients to return any affected product to their Eye Care Practitioner or purchase location for replacement or credit.

Details

Recall number
Z-3248-2026
Initiated
August 12, 2026
Posted by FDA
September 18, 2026
Product code
MVN – Lens, Contact, (Disposable)
Quantity
3060
Distribution
US Nationwide distribution in the states of MN, OH, WI.
Recalling firm
CooperVision, Inc., West Henrietta, NY

Official FDA recall record