Drug recall
AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are…
FDA recall event 64015 · Class II · Abbott Medical Optics Inc (AMO)
Key facts
| Event ID | 64015 |
|---|---|
| Recall numbers | Z-0929-2013 |
| Recalling firm | Abbott Medical Optics Inc (AMO) |
| Product type | Devices |
| Products | AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Two production orders of these IOLs that contain mislabeled IOLs. |
| Initiation date | Dec 20, 2012 |
| Report date | Mar 20, 2013 |
| Termination date | Jan 8, 2014 |
| City | Santa Ana |
| State | CA |
| Country | United States |
| FEI number | 3003843509 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: