Biofinity Toric Multifocal Contact Lens
Recall
- Recall Number
- Z-2166-2025
- Event Number
- 97173
- Firm
- CooperVision, Inc.
- FEI Number
- 1314956
- Product Code
- LPM
- Status
- Open, Classified
- Root Cause
- Use error
- Initiated
- June 16, 2025
- Posted
- July 23, 2025
- Address
- 711 North Rd, Scottsville, NY, 14546-1238
Description
Biofinity Toric Multifocal Contact Lens
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
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. Consignees are to complete and return the provided Correction Response Form via fax to 888-385-3217 or by email at [email protected]. Consignees with any complaints can contact the Customer Care Team at 855-526-6737; questions about this recall action can be directed to Customer Service at 800-341-2020.
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
827 units