Z-2153-2021Class II

FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker

Name: Z-2153-2021 FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
Creator: CooperVision Inc.
Published: 2021-05-19
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2021-05-19 / Terminated / root cause: manufacturing process

FDA source

CooperVision Inc. began a recall of FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker on 2021-05-19. FDA classified it as Class II and gives the reason as "Misaligned placement of an axis mark can cause the patient to experience blurred vision". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2153-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-19
Posted: 2021-07-27
Terminated: 2023-03-13
Recalling firm: CooperVision, Inc.
Product: FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Misaligned placement of an axis mark can cause the patient to experience blurred vision
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Coopervision issued Urgent Medical Device Correction letter on 5/19/21 to wholesale/distributor and Eye Care Practitioner level. The independent accounts via overnight FedEx (receipt tracking). Distributors and corporate accounts via email, with a read receipt. Letter states reason for recall, health risk and action to take: Examine your inventory for the affected lot numbers on the enclosed Ship Report. " Stop any further distribution of the specified lots of clariti 1 day toric lenses. " Dispose of the product and, within the next five (5) business days, please complete the attached Correction Response Form and fax it to 866-484-1048 or scan and email to: [email protected]. Your account will be credited once the form is received. If you have any further questions, please feel free to contact CooperVision Customer Service at 800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday.
Quantity in commerce: 180 lenses
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, NY, TN, OH, NC, WI and the countries of France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, Canada.
Product codes and lots: Lot Number: W0106186

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2153-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2143-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-27
Z-2144-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-27
Z-2145-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-27
Z-2146-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-27
Z-2147-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-27
Z-2148-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-27
Z-2149-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-27
Z-2150-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-27
Z-2151-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-27
Z-2152-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-27
Z-2153-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-27
Z-2154-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-27

Product code LPL

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