Drug recall
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of…
FDA recall event 66133 · Class II · Lumenis, Inc.
Key facts
| Event ID | 66133 |
|---|---|
| Recall numbers | Z-2191-2013 |
| Recalling firm | Lumenis, Inc. |
| Product type | Devices |
| Products | Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user. |
| Initiation date | Aug 19, 2013 |
| Report date | Sep 18, 2013 |
| Termination date | Dec 19, 2013 |
| City | Salt Lake City |
| State | UT |
| Country | United States |
| FEI number | 1720381 |
At a glance
- 1–9 Products in this recall
- 1–9 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: