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Class 2 Device Recall CLARITI 1 DAY TORIC Power |
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Date Initiated by Firm |
May 19, 2021 |
Create Date |
July 27, 2021 |
Recall Status1 |
Terminated 3 on March 13, 2023 |
Recall Number |
Z-2143-2021 |
Recall Event ID |
88096 |
510(K)Number |
K130331
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Product Classification |
Lenses, soft contact, daily wear - Product Code LPL
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Product |
CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
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Code Information |
Lot Number: R0121629 |
Recalling Firm/ Manufacturer |
CooperVision Inc. 180 Thruway Park Dr West Henrietta NY 14586-9798
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For Additional Information Contact |
SAME 585-756-9300
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Manufacturer Reason for Recall |
Misaligned placement of an axis mark can cause the patient to experience blurred vision
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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
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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.
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510(K) Database |
510(K)s with Product Code = LPL and Original Applicant = SAUFLON PHARMACEUTICALS, LTD.
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