Agency classClass IIIOur severity:Low FDA (Devices)·Z-1515-2018·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 packaging labeling error.

Plain-English summary

CooperVision Inc. is recalling Clariti 1 Day/Fresh Day 90 pack (-1.00) UV Blocking daily disposable contact lenses. The recall is due to the secondary packaging being labeled with an incorrect expiration date.

The affected product is Lot 14376100252004, with an expiration date of 7/31/2020 on the foil and 7/20/2031 on the carton. The quantity involved is 22 packs, containing 1,980 lenses. The product was 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 with this product should stop using it and contact CooperVision Inc. for further instructions. The FDA has classified this as a Class III recall, indicating that use of the product is not likely to cause adverse health consequences.

The recalled product

Product: clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon 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…
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 14376100252004
Exp. Date 7/31/2020 (foil)
7/20/2031 (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