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U.S. Department of Health and Human Services

Class 2 Device Recall CLARITI 1 DAY TORIC Power

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  Class 2 Device Recall CLARITI 1 DAY TORIC Power see related information
Date Initiated by Firm May 19, 2021
Create Date July 27, 2021
Recall Status1 Terminated 3 on March 13, 2023
Recall Number Z-2146-2021
Recall Event ID 88096
510(K)Number K130331  
Product Classification Lenses, soft contact, daily wear - Product Code LPL
Product CLARITI 1 DAY TORIC Power -07.00 -1.75/170

Daily Disposable Contact Lens with UV blocker
Code Information Lot Number: U0108833          
Recalling Firm/
Manufacturer		 CooperVision Inc.
180 Thruway Park Dr
West Henrietta NY 14586-9798
For Additional Information Contact SAME
585-756-9300
Manufacturer Reason
for Recall		 Misaligned placement of an axis mark can cause the patient to experience blurred vision
FDA Determined
Cause 2		 Equipment maintenance
Action Coopervision issued Urgent Medical Device Correction letter on 5/19/21 to wholesale/distributor and Eye Care Practitioner level. The independent accounts via overnight FedEx (receipt tracking). Distributors and corporate accounts via email, with a read receipt. Letter states reason for recall, health risk and action to take: Examine your inventory for the affected lot numbers on the enclosed Ship Report. " Stop any further distribution of the specified lots of clariti 1 day toric lenses. " Dispose of the product and, within the next five (5) business days, please complete the attached Correction Response Form and fax it to 866-484-1048 or scan and email to: info@coopervision.com. Your account will be credited once the form is received. If you have any further questions, please feel free to contact CooperVision Customer Service at 800-341-2020, 9:00 AM  7:00 PM ET, Monday  Friday.
Quantity in Commerce 90 lenses
Distribution Worldwide distribution - US Nationwide distribution in the states of FL, NY, TN, OH, NC, WI and the countries of France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, Canada.
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 = LPL and Original Applicant = SAUFLON PHARMACEUTICALS, LTD.
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