Z-1516-2018Class III

clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti...

Name: Z-1516-2018 clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti...
Creator: CooperVision Inc.
Published: 2018-02-21
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2018-02-21 / Terminated / root cause: labeling and UDI

FDA source

CooperVision Inc. began a recall of clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily... on 2018-02-21. FDA classified it as Class III and gives the reason as "The secondary packaging is labeled with an incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1516-2018
Classification: Class III
Status: Terminated
Initiated: 2018-02-21
Posted: 2018-04-25
Terminated: 2019-10-02
Recalling firm: CooperVision, Inc.
Product: clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
Product code: MVN Lens, Contact, (Disposable)
Reason for recall: The secondary packaging is labeled with an incorrect expiration date.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: The firm, CooperVision, sent an "Firm Initiated Voluntary Removal - ACTION REQUIRED" letter to its customers on 2/21/18. The letter describes the product, problem and actions to be taken. The letters instructed customers to: Examine your inventory for any affected lot numbers; Stop any further distribution of the specified lot(s) of clariti 1 day and Fresh Day contact lenses; discard product and contact CooperVision, Inc. Customer Service department at 1-800-341-2020 to receive credit and/or complimentary replacement product. The removal only affects clariti 1 day lenses with the lot numbers specified on the enclosed letter. No other clariti 1 day and Fresh Day products or any other CooperVision products are affected. If you have any further questions, please feel free to contact your Account Representative or Customer Service at 1-800-341-2020, 9:00 AM 7:00 PM ET, Monday - Friday.
Quantity in commerce: 32 packs/2880 lenses
Distribution: US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.
Product codes and lots: Lot 14377101733005, Exp. Date 6/30/2020 (foil); 6/20/2030 (carton)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1516-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1515-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-25
Z-1516-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-25
Z-1517-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-25
Z-1518-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-25

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