Class 2 Device Recall Biofinity Toric Multifocal

• Date Initiated by Firm: August 29, 2024
• Date Posted: September 30, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3311-2024
• Recall Event ID: 95299
• Product Classification: Lenses, soft contact, extended wear - Product Code LPM
• Product: Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
• Code Information: UDI-DI: N/A Lot Numbers: RB0444532 RB0450357 RB0450370 RB0450372 RB0450378 RB0450379 RB0450407 RB0450419 RB0450422 RB0450429 RB0450438 RB0450446 RB0450455 RB0450457 RB0450465 RB0450466 RB0450477 RB0450478 RB0450496 RB0450501 RB0450504 RB0450542 RB0450547 RB0450548 RB0450560 RB0450561 RB0450575 RB0450594 RB0450613 RB0450625 RB0450636 RB0450646 RB0450649 RB0450653 RB0450657 RB0450659 RB0450686 RB0450687 RB0450688 RB0450691 RB0450693 RB0450694 RB0450695 RB0450697 RB0450699 RB0450701 RB0450702 RB0450707 RB0450708 RB0450709 RB0450710 RB0450714 RB0450719 RB0450727 RB0450730 RB0450739 RB0450746 RB0450748 RB0450753 RB0450767 RB0450770 RB0450776 RB0450827 RB0450864 RB0450887 RB0450957 RB0451097 RB0451099 RB0451101 RB0451104 RB0451106 RB0451107 RB0451122 RB0451127 RB0451130 RB0451134 RB0451135 RB0451136 RB0451137 RB0451139 RB0451403 RB0451430 RB0451433 RB0451442 RB0451443 RB0451451 RB0451456 RB0451462 RB0451468 RB0451485 RB0451488 RB0451546 RB0451553 RB0451558 RB0451587 RB0451593 RB0451604 RB0451611 RB0451622 RB0451627 RB0451644 RB0451648 RB0451657 RB0451658 RB0451666 RB0451671 RB0451685 RB0451687 RB0451691 RB0451697 RB0451706 RB0451707 RB0451713 RB0451720 RB0451724 RB0451725 RB0451729 RB0451730 RB0451731 RB0451736 RB0451737 RB0451738 RB0451746 RB0451748 RB0451750 RB0451751 RB0451761 RB0451788 RB0451789 RB0451790 RB0451791 RB0451792 RB0451794 RB0451801 RB0451810 RB0451812 RB0451813 RB0451817 RB0451823 RB0451824 RB0451828 RB0451841 RB0451842 RB0451843 RB0451844 RB0451845 RB0451847 RB0451883 RB0451884 RB0451945 RB0451957 RB0451958 RB0451961 RB0451964 RB0451965 RB0451966 RB0451973 RB0451976 RB0451978 RB0451982 RB0451983 RB0451987 RB0451993 RB0452006 RB0452009 RB0452010 RB0452012 RB0452016 RB0452018 RB0452020 RB0452027 RB0452028 RB0452035 RB0452036 RB0452042 RB0452045 RB0452104 RB0452107 RB0452133 RB0452159 RB0452164 RB0452171 RB0452215 RB0452219 RB0452227 RB0452228 RB0452229 RB0452230 RB0452231 RB0452239 RB0452242 RB0452243 RB0452246 RB0452255 RB0452258 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• FEI Number: 3005724763
• Recalling Firm/ Manufacturer: CooperVision, Inc.; 180 Thruway Park Dr; West Henrietta NY 14586-9798
• For Additional Information Contact: Annette Nelson; 585-756-9300
• Manufacturer Reason for Recall: Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
• FDA Determined Cause: Process control
• Action: CooperVision issued Urgent Medical Device Correction letter (Customer specific) beginning 8/30/24 to Distributors, Eye Care Practitioners, Consumers. Letter states reason for recall, health risk and action to take: Stop any further distribution of product from the designated lot numbers; " We recommend authorized distributors contact your accounts and Eye Care Practitioners contact your patients who have received the affected product with the enclosed draft Consumer Communication Letter, to be completed by the Eye Care Practitioner s office. " Please instruct any patients to return any affected product to their Eye Care Practitioner for replacement or credit. " Within the next five (5) business days, please complete the attached Correction Response Form and fax it to 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 ; " Dispose of the affected product in your inventory or that is returned to you. " 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 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 .
• Quantity in Commerce: 2443 lenses
• Distribution: Worldwide distribution - US Nationwide and 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.