MAUDE manufacturer profile
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER · GEX
MAUDE profile for Powered Laser Surgical Instrument
Key facts
| Manufacturer | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
|---|---|
| Manufacturer group | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Product code | GEX |
| Product code name | Powered Laser Surgical Instrument |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Patient Involvement, No Consequences Or Impact To Patient, Power Problem, Device Operates Differently Than Expected, Failure to Fire, Device Inoperable, Failure to Power Up Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1