MAUDE manufacturer profile
LENSAR, INC · OOE
MAUDE profile for Ophthalmic Femtosecond Laser
Key facts
| Manufacturer | LENSAR, INC |
|---|---|
| Manufacturer group | LENSAR, INC |
| Product code | OOE |
| Product code name | Ophthalmic Femtosecond Laser |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Capsular Bag Tear, No Information, Corneal Perforation, Patient Device Interaction Problem, Insufficient Information, Improper or Incorrect Procedure or Method, Patient-Device Incompatibility 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