Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Recall
- Recall Number
- Z-1197-2023
- Event Number
- 91607
- Firm
- CooperVision, Inc.
- FEI Number
- 3005724763
- Product Code
- LPM
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- January 26, 2023
- Posted
- March 1, 2023
- Address
- 180 Thruway Park Dr, West Henrietta, NY, 14586-9798
Description
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
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.
US Nationwide distribution in the states of CA, OH, NC, PA.
24 units