Recall Z-3248-2026— CooperVision, Inc.
Class II · Ongoing
Class II FDA medical device recall by CooperVision, Inc., initiated 2026-08-12. It names one FDA 510(k) clearance: K130331. Product: Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day. Reason: A small number of lenses within the affected lot are of the incorrect power..
- Recalling firm
- CooperVision, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-12
- Firm location
- West Henrietta, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.