Drug recall
Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact…
FDA recall event 79073 · Class III · CooperVision Inc.
Key facts
| Event ID | 79073 |
|---|---|
| Recall numbers | Z-0691-2018 |
| Recalling firm | CooperVision Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Sep 1, 2017 |
| Report date | Mar 7, 2018 |
| Termination date | Jul 30, 2018 |
| City | W Henrietta |
| State | NY |
| Country | United States |
| FEI number | 3005724763 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: