FDA Medical devices recall ·
Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model recall
- Recall number
- Z-3248-2026
- Date
- (initiated August 12, 2026)
- Company / brand
- CooperVision, Inc.
180 Thruway Park Dr, West Henrietta, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3060
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
Why was it recalled?
A small number of lenses within the affected lot are of the incorrect power.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Pearle Vision 1 day; Carton Lot # 11727620152030; Blister Lot # CB132348;
Distribution
US Nationwide distribution in the states of MN, OH, WI.
States: Minnesota Ohio Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3248-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.