Recall Z-1198-2023 ยท LPM Lenses, Soft Contact, Extended Wear
CooperVision, Inc.
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
| Date | Mar 1, 2023 (initiated Jan 26, 2023) |
| Status | Open, Classified |
| Reason | Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity |
| Root cause | 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 pr |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of CA, OH, NC, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.