{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198890", "product_res_number": "Z-1282-2023", "event_date_initiated": "2023-02-14", "event_date_posted": "2023-03-23", "recall_status": "Open, Classified", "res_event_number": "91793", "product_code": "LPL", "k_numbers": [ "K181920" ], "product_description": "Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90", "code_info": "Lot Number W0124677", "firm_fei_number": "3005724763", "recalling_firm": "CooperVision, Inc.", "address_1": "180 Thruway Park Dr", "city": "West Henrietta", "state": "NY", "postal_code": "14586-9798", "additional_info_contact": "CooperVision Customer Service\n800-341-2020", "reason_for_recall": "The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.", "root_cause_description": "Process control", "action": "An URGENT MEDICAL DEVICE CORRECTION letter dated 2/14/23 was sent to customers.\n\nEye Care Practitioner/Distributor Instructions:\nOur records indicate you have received product from the affected lot. We request you take the following actions:\n\" 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.\n\" Stop any further distribution of product from the designated lot number;\n\" 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.\n\" Enclosed you will find a template letter that can be customized by an Eye Care Practitioner for distribution to their patients.\n\" 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 ;\n\" Your account will be credited once the form is received.\n\" 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.\nPlease 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.\nWe 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,", "product_quantity": "3150", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and WI. 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