MAUDE manufacturer profile
ALCON - IRVINE TECHNOLOGY CENTER · HQC
MAUDE profile for Unit, Phacofragmentation
Key facts
| Manufacturer | ALCON - IRVINE TECHNOLOGY CENTER |
|---|---|
| Manufacturer group | ALCON - IRVINE TECHNOLOGY CENTER |
| Product code | HQC |
| Product code name | Unit, Phacofragmentation |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Device Operational Issue, No Patient Involvement, Aspiration Issue, Failure to Cut, Adverse Event Without Identified Device or Use Problem, Device Operates Differently Than Expected, Device Inoperable 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