Device recall
Z-0165-2012: Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers…
FDA device recall · Class II · AMO Manufacturing USA, LLC
Key facts
| Recall number (Z-number) | Z-0165-2012 |
|---|---|
| Recall event | 60241 |
| Product | Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond… |
| Product code | HNO |
| Recalling firm | AMO Manufacturing USA, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 1, 2013 |
| 510(k) numbers | K031960 |
| FEI number | 3006695864 |
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