The Recall Desk
LowFDA (Devices)·Z-1518-2018·Announced 2018-05-02

CooperVision Clariti 1 Day Contact Lenses Recalled for Incorrect Expiration Date

CooperVision is recalling specific lots of Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging labeling error regarding the expiration date, which falls under the 'Low' severity criteria for documentation or packaging-only problems.

Plain-English summary

CooperVision Inc. is recalling 105 packs (1,050 lenses) of Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker. The specific product affected is the 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lens. The recall is limited to Lot 14364100370010, with an expiration date of 3/31/2020 on the foil and 5/31/2020 on the carton.

The reason for the recall is that the secondary packaging is labeled with an incorrect expiration date. This is a documentation and labeling issue rather than a defect in the lens material itself.

The product was distributed nationwide in the United States to the 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. Consumers should check their contact lens packaging for the specific lot number and expiration dates listed above. If the product matches the recalled lot, consumers should stop using it and contact the manufacturer for further instructions.

The recalled product

Product
56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, 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
Manufacturer
CooperVision Inc.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot 14364100370010
  • Exp. Date 3/31/2020 (foil)
  • 5/31/2020 (carton)

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 4 recalled by CooperVision Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →