MAUDE manufacturer profile
WAVELIGHT GMBH · OOE
MAUDE profile for Ophthalmic Femtosecond Laser
Key facts
| Manufacturer | WAVELIGHT GMBH |
|---|---|
| Manufacturer group | WAVELIGHT GMBH |
| Product code | OOE |
| Product code name | Ophthalmic Femtosecond Laser |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Keratitis, No Known Impact Or Consequence To Patient, Failure to Align, Device Operates Differently Than Expected, Insufficient Information, No Code Available 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