Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
FDA Recall Z-1282-2023 · Posted 2023-03-23
Recalling FirmCooperVision, Inc.
Recall StatusOpen, Classified
Product CodeLPL
Date Initiated2023-02-14
Product Quantity3150
Reason for Recall
The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
Firm 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: [email protected]. 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,
Root Cause
Process control
Distribution Pattern
Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and WI. The country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.