Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90

FDA device recall Z-1282-2023 · posted 2023-03-23 · Open, Classified

Recall details

Recalling firm

CooperVision, Inc.

Reason for recall

The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.

Action taken

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,

Root cause

Process control

Status

Open, Classified

Product code

LPL

Quantity affected

3150

Distribution

Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and WI. The country of Canada.

Date initiated

2023-02-14

Date posted

2023-03-23

Location

West Henrietta, NY

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