Drug recall
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular…
FDA recall event 67283 · Class II · Bausch & Lomb Surgical, Inc.
Key facts
| Event ID | 67283 |
|---|---|
| Recall numbers | Z-1062-2014 |
| Recalling firm | Bausch & Lomb Surgical, Inc. |
| Product type | Devices |
| Products | Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lens was manufactured with incorrect raw material. |
| Initiation date | Oct 16, 2013 |
| Report date | Feb 26, 2014 |
| Termination date | Sep 17, 2014 |
| City | Clearwater |
| State | FL |
| Country | United States |
| FEI number | 1119279 |
At a glance
- 1–9 Products in this recall
- None 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: