FDA Medical Device Recalls (openFDA)
CooperVision, Inc.: Biofinity Toric Multifocal Contact Lens
- Recall number
- Z-2166-2025
- Recalling firm
- CooperVision, Inc.
- Product
- Biofinity Toric Multifocal Contact Lens
- Status
- Open, Classified
- Initiated
- 2025-06-16
- Posted
- 2025-07-23
- Terminated
- not on file
- 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. Consignees are to complete and return the provided Correction Response Form via fax to 888-385-3217 or by email at info@coopervision.com. 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.
- Quantity
- 827 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
- Lot, serial or model codes
- Carton Lot Numbers: RB0682365, RB0684301, RB0684305, RB0684311, RB0684313, RB0684317, RB0684321, RB0684325, RB0684335, RB0684506, RB0684575, RB0684582, RB0684653, RB0684657, RB0684659, RB0684663, RB0684664, RB0684667, RB0684668, RB0684669, RB0684670, RB0684673, RB0684674, RB0684676, RB0684682, RB0686359, RB0687092, RB0687368, RB0687370, RB0687547, RB0687582, RB0687586, RB0687665, RB0687693, RB0687797, RB0687800, RB0687801, RB0687802, RB0687803, RB0687807, RB0687812, RB0687822, RB0687893, RB0687897, RB0687904, RB0687908, RB0687910, RB0687922, RB0688105, RB0688107, RB0688109, RB0688113, RB0688117, RB0688121, RB0688128, RB0688130, RB0688145, RB0688147, RB0688151, RB0688163, RB0688170, RB0688174, RB0688269, RB0688298, RB0688300, RB0688305, RB0688307, RB0688320, RB0688322, RB0688343, RB0688492, RC1756323, RC1759660, RC1759663, RC1759931, RC1759947, RC1759965, RC1759967
- 510(k) numbers
- not on file
- PMA numbers
- ["P080011"]
- Product code
- LPM
- Firm FEI
- 1314956
- Firm city
- Scottsville
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28