Device recall
Z-0206-2016: BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue…
FDA device recall · Class II · Bausch & Lomb Inc Irb
Key facts
| Recall number (Z-number) | Z-0206-2016 |
|---|---|
| Recall event | 72161 |
| Product | BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue… |
| Product code | LPL |
| Recalling firm | Bausch & Lomb Inc Irb |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 6, 2016 |
| 510(k) numbers | K113703 |
| FEI number | 1317628 |
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