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U.S. Department of Health and Human Services

Class 3 Device Recall 56 1 Day Silicone Hydrogel (10 pack)

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  Class 3 Device Recall 56 1 Day Silicone Hydrogel (10 pack) see related information
Date Initiated by Firm February 21, 2018
Create Date April 25, 2018
Recall Status1 Terminated 3 on October 02, 2019
Recall Number Z-1517-2018
Recall Event ID 79755
510(K)Number K130331  
Product Classification Lens, contact, (disposable) - Product Code MVN
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 (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.
Code Information Lot 14364100237018, Exp. Date 9/30/2020 (foil); 9/30/2022 (carton)
Recalling Firm/
CooperVision Inc.
180 Thruway Park Dr
W Henrietta NY 14586-9798
For Additional Information Contact Account Rep/Customer Service
Manufacturer Reason
for Recall
The secondary packaging is labeled with an incorrect expiration date.
FDA Determined
Cause 2
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 328 packs/3280 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MVN and Original Applicant = SAUFLON PHARMACEUTICALS, LTD.