Recall Z-3248-2026 ยท MVN Lens, Contact, (Disposable)
CooperVision, Inc.
Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
| Date | Sep 18, 2026 (initiated Aug 12, 2026) |
| Status | Open, Classified |
| Reason | A small number of lenses within the affected lot are of the incorrect power. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 3060 |
| Distribution | US Nationwide distribution in the states of MN, OH, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130331 | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER Sauflon Pharmaceuticals, Ltd., Jul 26, 2013 |