Device recall
Z-0531-2014: Viscocel and Viscocel Plus. These products are intraocular fluid devices…
FDA device recall · Class I · C.L.R. Medicals International, Inc.
Key facts
| Recall number (Z-number) | Z-0531-2014 |
|---|---|
| Recall event | 66930 |
| Product | Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a… |
| Product code | LZP |
| Recalling firm | C.L.R. Medicals International, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 5, 2014 |
| FEI number | 3004172696 |
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