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Terminated

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 (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.

FDA Recall Z-1517-2018 · Posted None

Recalling FirmCooperVision Inc.
Recall StatusTerminated
Product CodeMVN
Date Initiated2018-02-21
Date Terminated2019-10-02
Product Quantity328 packs/3280 lenses

Reason for Recall

The secondary packaging is labeled with an incorrect expiration date.

Firm 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.

Root Cause

Incorrect or no expiration date

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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