← FDA ENFORCEMENT
Z-3248-2026Class II

CooperVision, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
CooperVision, Inc.
Product type
Device
Status
Ongoing
Report date
2026-09-30
Distribution
US Nationwide distribution in the states of MN, OH, WI.
Firm state
NY
Product quantity
3060
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

Pearle Vision 1 day; Carton Lot # 11727620152030; Blister Lot # CB132348;

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →