Recall Z-3248-2026
CooperVision, Inc. · initiated August 12, 2026
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