Z-1282-2023Class II

Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90

Name: Z-1282-2023 Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
Creator: CooperVision, Inc.
Published: 2023-02-14
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2023-02-14 / Open, Classified / root cause: manufacturing process

FDA source

CooperVision, Inc. began a recall of Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90 on 2023-02-14. FDA classified it as Class II and gives the reason as "The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1282-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-14
Posted: 2023-03-23
Recalling firm: CooperVision, Inc.
Product: Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An URGENT MEDICAL DEVICE CORRECTION letter dated 2/14/23 was sent to customers. Eye Care Practitioner/Distributor Instructions: Our records indicate you have received product from the affected lot. We request you take the following actions: " Please examine your inventory/product shelf for any of the provided affected lot number. The lot number can be found on the back panel of the carton below the expiration date. Below is an example and where to locate the lot number. " Stop any further distribution of product from the designated lot number; " We recommend you contact your Eye Care Practitioners or patients who have received the affected product. Any affected product should be returned to you or CooperVision for replacement or credit. " Enclosed you will find a template letter that can be customized by an Eye Care Practitioner for distribution to their patients. " Within the next five (5) business days, complete the attached Correction Response Form and fax it to 1-888-385-3217 or scan and email to: [email protected]. If you have no lenses from these specified lots, please put 0 in Quantity ; " Your account will be credited once the form is received. " If your patients have questions or complaints, please have them contact our customer services team at 1-800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday, or they can visit CooperVision s website at coopervision.com/our-company/contact-us/complaint. Please note that if a credit is due to you, this will automatically be applied to your account once we have received and validated your Correction Response Form . This action is being reported to applicable health authorities and CooperVision may be required to identify any consignees that do not respond. We appreciate your assistance and apologize for any inconvenience to you or your customers. Should you wish to discuss this action, please contact your business development manager or our CooperVision Customer Service at: 1-800-341-2020, 9:00 AM 7:00 PM ET,
Quantity in commerce: 3150
Distribution: Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and WI. The country of Canada.
Product codes and lots: Lot Number W0124677

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1282-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1282-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-23

Product code LPL

K181920Class IIClariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV BlockerCooperVision, Inc. / cleared 2018-12-11

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)