Z-3248-2026Class II

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

Name: Z-3248-2026 Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision...
Creator: CooperVision, Inc.
Published: 2026-08-12
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2026-08-12 / Open, Classified

FDA source

Recall record

Recall number: Z-3248-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-12
Posted: 2026-09-18
Recalling firm: CooperVision, Inc.
Product: Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
Product code: MVN Lens, Contact, (Disposable)
Reason for recall: A small number of lenses within the affected lot are of the incorrect power.
FDA root cause: Process control
Action: On August 24, 2026 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Please stop any further distribution of products from the designated lot number. 2. Dispose of the affected product in your inventory or that is returned to you. 3. Within the next five (5) business days, please complete the response form provided and return it. If you have no lenses from these specified lots, please put 0 in Quantity and return the form. 4. We recommend authorized distributors contact your accounts, and Eye Care Practitioners contact your patients who have received the affected product, with the enclosed Customer Communication Letter . 5. Please instruct any patients to return any affected product to their Eye Care Practitioner or purchase location for replacement or credit.
Quantity in commerce: 3060
Distribution: US Nationwide distribution in the states of MN, OH, WI.
Product codes and lots: Pearle Vision 1 day; Carton Lot # 11727620152030; Blister Lot # CB132348;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3248-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3248-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18

Product code MVN

K130331Class IISauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV BlockerSauflon Pharmaceuticals, Ltd. / cleared 2013-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)