CooperVision, Inc. recalls Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catal…

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

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-3248-2026
• FDA 510(k) clearance · K130331The device's official FDA premarket clearance record
• FDA device classification · MVNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.5925The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CooperVision, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.