Device recall
Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
- Recall number
- Z-3248-2026
- Event id
- 99766
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- CooperVision, Inc.
- Report date
- Sep 30, 2026
- Posted
- Sep 18, 2026
- Initiated
- Aug 12, 2026
- Center classification date
- Sep 18, 2026
- Product code
- MVN
- Device type
- Lens, Contact, (Disposable)
- Reason
- A small number of lenses within the affected lot are of the incorrect power.
- Root cause
- Process control
- Quantity
- 3060
- Code info
- Pearle Vision 1 day; Carton Lot # 11727620152030; Blister Lot # CB132348;
- Distribution
- US Nationwide distribution in the states of MN, OH, WI.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K130331
- Location
- West Henrietta, NY, United States