Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)

FDA device recall Z-1198-2023 · posted 2023-03-01 · Open, Classified

Recall details

Recalling firm

CooperVision, Inc.

Reason for recall

Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity

Action taken

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.

Root cause

Employee error

Status

Open, Classified

Product code

LPM

Quantity affected

4 units

Distribution

US Nationwide distribution in the states of CA, OH, NC, PA.

Date initiated

2023-01-26

Date posted

2023-03-01

Location

West Henrietta, NY