Device recall
Z-0542-2014: Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses…
FDA device recall · Class II · CooperVision Inc.
Key facts
| Recall number (Z-number) | Z-0542-2014 |
|---|---|
| Recall event | 66844 |
| Product | Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses |
| Product code | MVN |
| Recalling firm | CooperVision Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2015 |
| 510(k) numbers | K061948 |
| 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