BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1282-2023 · Initiated February 14, 2023

    Recall

    Recall Number
    Z-1282-2023
    Event Number
    91793
    Firm
    CooperVision, Inc.
    FEI Number
    3005724763
    Product Code
    LPL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 14, 2023
    Posted
    March 23, 2023
    Address
    180 Thruway Park Dr, West Henrietta, NY, 14586-9798

    Description

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

    Reason

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

    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,

    Distribution

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

    Quantity

    3150