Device recall
Z-1518-2018: 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable…
FDA device recall · Class III · CooperVision Inc.
Key facts
| Recall number (Z-number) | Z-1518-2018 |
|---|---|
| Recall event | 79755 |
| Product | 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in… |
| Product code | MVN |
| Recalling firm | CooperVision Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 2, 2019 |
| 510(k) numbers | K130331 |
| 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