Device recall
Z-1336-2013: ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact…
FDA device recall · Class II · Johnson & Johnson Vision Care, Inc.
Key facts
| Recall number (Z-number) | Z-1336-2013 |
|---|---|
| Recall event | 64468 |
| Product | ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D of… |
| Product code | LPL |
| Recalling firm | Johnson & Johnson Vision Care, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 5, 2013 |
| 510(k) numbers | K062614 |
| FEI number | 1000222023 |
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