Device recall
Z-0530-2015: Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate…
FDA device recall · Class II · Abbott Medical Optics Inc (AMO)
Key facts
| Recall number (Z-number) | Z-0530-2015 |
|---|---|
| Recall event | 69704 |
| Product | Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical… |
| Product code | LZP |
| Recalling firm | Abbott Medical Optics Inc (AMO) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 19, 2015 |
| PMA numbers | P110007, P810031 |
| FEI number | 3003843509 |
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