Class 2 Device Recall Clariti 1 day toric

• Date Initiated by Firm: February 14, 2023
• Date Posted: March 23, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1282-2023
• Recall Event ID: 91793
• 510(K)Number: K181920
• Product Classification: Lenses, soft contact, daily wear - Product Code LPL
• Product: Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
• Code Information: Lot Number W0124677
• Recalling Firm/ Manufacturer: CooperVision, Inc.; 180 Thruway Park Dr; West Henrietta NY 14586-9798
• For Additional Information Contact: CooperVision Customer Service; 800-341-2020
• Manufacturer Reason for Recall: The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
• FDA Determined Cause: Process control
• Action: An URGENT MEDICAL DEVICE CORRECTION letter dated 2/14/23 was sent to customers. Eye Care Practitioner/Distributor Instructions: Our records indicate you have received product from the affected lot. We request you take the following actions: " Please examine your inventory/product shelf for any of the provided affected lot number. The lot number can be found on the back panel of the carton below the expiration date. Below is an example and where to locate the lot number. " Stop any further distribution of product from the designated lot number; " We recommend you contact your Eye Care Practitioners or patients who have received the affected product. Any affected product should be returned to you or CooperVision for replacement or credit. " Enclosed you will find a template letter that can be customized by an Eye Care Practitioner for distribution to their patients. " Within the next five (5) business days, complete the attached Correction Response Form and fax it to 1-888-385-3217 or scan and email to: info@coopervision.com. If you have no lenses from these specified lots, please put 0 in Quantity ; " Your account will be credited once the form is received. " If your patients have questions or complaints, please have them contact our customer services team at 1-800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday, or they can visit CooperVision s website at coopervision.com/our-company/contact-us/complaint. Please note that if a credit is due to you, this will automatically be applied to your account once we have received and validated your Correction Response Form . This action is being reported to applicable health authorities and CooperVision may be required to identify any consignees that do not respond. We appreciate your assistance and apologize for any inconvenience to you or your customers. Should you wish to discuss this action, please contact your business development manager or our CooperVision Customer Service at: 1-800-341-2020, 9:00 AM 7:00 PM ET,
• Quantity in Commerce: 3150
• Distribution: Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and WI. The country of 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LPL and Original Applicant = CooperVision, Inc.