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U.S. Department of Health and Human Services

Class 2 Device Recall Biofinity XR Toric

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  Class 2 Device Recall Biofinity XR Toric see related information
Date Initiated by Firm January 26, 2023
Date Posted March 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-1197-2023
Recall Event ID 91607
PMA Number P080011 
Product Classification Lenses, soft contact, extended wear - Product Code LPM
Product Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Code Information UDI: N/A Lot Numbers: R24377024, R24377026, R24381716, R24416900
Recalling Firm/
Manufacturer		 CooperVision, Inc.
180 Thruway Park Dr
West Henrietta NY 14586-9798
For Additional Information Contact SAME
585-756-9300
Manufacturer Reason
for Recall		 Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
FDA Determined
Cause 2		 Employee error
Action Coopervision issued Urgent Medical Device Correction letter on 1/26/23 to direct consignees requesting end users be notified. Letter states reason for recall, health risk and action to take: Please examine your inventory/product shelf for any of the provided affected lot numbers. 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 numbers; " We recommend you contact your Eye Care Practitioners or patients who have received the affected product. Please instruct Eye Care Practitioners or patients to return any affected product to you for replacement or credit. " Enclosed you will find a template that can be customized by the ECP for distribution to their patients. 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. Should you wish to discuss this action, please contact your business development manager or our customer services team at: 800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday.
Quantity in Commerce 24 units
Distribution US Nationwide distribution in the states of CA, OH, NC, PA.
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.
PMA Database PMAs with Product Code = LPM and Original Applicant = CooperVision, Inc.
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