Z-3248-2026 Class II Ongoing

Recalled by CooperVision, Inc. — West Henrietta, NY

FDA device recall Z-3248-2026 was initiated by CooperVision, Inc. on Aug 12, 2026 and is designated Class II. Reason for recall: A small number of lenses within the affected lot are of the incorrect power. The recall status is ongoing. Affected quantity: 3060.

Recall Details

Product Type
Devices
Report Date
Sep 30, 2026
Initiation Date
Aug 12, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3060

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide distribution in the states of MN, OH, WI.

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-3248-2026
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.