Recall Z-0691-2018 ยท LPM Lenses, Soft Contact, Extended Wear
CooperVision Inc.
Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters. The Biofinity (comfilcon A) Soft (Hydrop
| Date | Sep 1, 2017 |
| Status | Terminated |
| Reason | The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The primary blister reads Biofinity Multifocal Toric in error, and should read Biofinity XR Toric. The outer carton correctly reads Biofinity XR Toric. |
| Root cause | Employee error |
| Action | Notifications were sent with instructions to examine inventory, discard any affected inventory, and contact the firm for credit or replacement. For further questions, please call (585) 756-9273. |
| Quantity | 120 |
| Distribution | USA Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS CooperVision, Inc., Dec 6, 2005 |