Device recall
Z-0691-2018: Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon…
FDA device recall · Class III · CooperVision Inc.
Key facts
| Recall number (Z-number) | Z-0691-2018 |
|---|---|
| Recall event | 79073 |
| Product | 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… |
| Product code | LPM |
| Recalling firm | CooperVision Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 30, 2018 |
| 510(k) numbers | K052560 |
| FEI number | 3005724763 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database