Device recall
Z-0164-05: Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles…
FDA device recall · Class II · 1-800 Contacts Inc.
Key facts
| Recall number (Z-number) | Z-0164-05 |
|---|---|
| Recall event | 30238 |
| Product | Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer box reads in part: 'CooperVision proclear compatibles (omafilcon A) ***Norfolk, VA *** MADE IN USA ** Tinted soft contact lenses *** in a buffered 0.9% saline solution***''. |
| Product code | MVN |
| Recalling firm | 1-800 Contacts Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 25, 2005 |
| FEI number | 3003106412 |
At a glance
- None 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