MAUDE manufacturer profile
WAVELIGHT GMBH · GEX
MAUDE profile for Powered Laser Surgical Instrument
Key facts
| Manufacturer | WAVELIGHT GMBH |
|---|---|
| Manufacturer group | WAVELIGHT GMBH |
| Product code | GEX |
| Product code name | Powered Laser Surgical Instrument |
At a glance
- 1,000+ MAUDE reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Insufficient Information, Keratitis, Failure to Align, Suction Problem, Decrease in Suction, Device Operates Differently Than Expected 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