Device recall
Z-2302-2008: Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265…
FDA device recall · Class III · Porex Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-2302-2008 |
|---|---|
| Recall event | 48722 |
| Product | Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265. The device is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process. |
| Product code | HQN |
| Recalling firm | Porex Surgical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 10, 2008 |
| 510(k) numbers | K972034 |
| FEI number | 1000131961 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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