Agency classClass IIIOur severity:Low FDA (Devices)·Z-1517-2018·Announced 2018-05-02

CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date

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

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/packaging labeling error.

Plain-English summary

CooperVision Inc. is recalling 328 packs (3,280 lenses) of Clariti 1 Day (somofilcon A) Soft Daily Disposable Contact Lenses with UV blocker. The specific product affected is the 56% 1 Day Silicone Hydrogel (-4.50) 10-pack. The recall is due to a labeling error where the secondary packaging is labeled with an incorrect expiration date.

The affected lot number is 14364100237018. The expiration date on the foil is 9/30/2020, and the expiration date on the carton is 9/30/2022. The products were distributed nationwide to specific states including 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 who have purchased these specific contact lenses should stop using them and contact CooperVision Inc. for further instructions or a refund. This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product: 56% 1 Day Silicone Hydrogel (-4.50), 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.
Category: Medical Device — Contact Lenses
Hazard: mis-labeling

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 14364100237018
Exp. Date 9/30/2020 (foil)
9/30/2022 (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 →

Same manufacturer · CooperVision Inc.

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Same hazard · mis labeling