Recall Z-2165-2025 ยท LPM Lenses, Soft Contact, Extended Wear
CooperVision, Inc.
Biofinity XR Toric Contact Lens
| Date | Jul 23, 2025 (initiated Jun 16, 2025) |
| Status | Open, Classified |
| Reason | Lens blisters may have an incomplete or leaking seal which may render them unsterile. |
| Root cause | Use error |
| Action | An URGENT MEDICAL DEVICE CORRECTION notice dated 6/27/25 was mailed to distributors, retailers, and physicians notifying them of this recall. The notification instructs consignees to inspect their inventory for affected devices and stop any further distribution/sale of affected devices. Practitioners are instructed to share the provided Consumer Communication Letter with any patients who received affected devices and to have patients return any units in their possession for replacement or credit. Consignees are to dispose of any affected product in their inventory or that is returned. Consigne |
| Quantity | 397 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.