Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
FDA Recall Z-3248-2026 · Posted 2026-09-18
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Recalling FirmCooperVision, Inc.
Recall StatusOpen, Classified
Product CodeMVN
Date Initiated2026-08-12
Product Quantity3060
Reason for Recall
A small number of lenses within the affected lot are of the incorrect power.
Firm 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 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of MN, OH, WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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