FDA Adverse Event
Injury
Summary report: N
MILLENNIUM MICROSURGICAL SYSTEM
MDR report key: 2000992
·
Received February 18, 2011
Report
- Report Number
- 1920664-2011-00004
- Event Type
- Injury
- Date Received
- February 18, 2011
- Date of Event
- January 21, 2011
- Report Date
- January 21, 2011
- Manufacturer
- BAUSCH + LOMB
- Product Code
- HQC
- PMA / PMN Number
- K961310
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE MACHINE WAS INSPECTED BY OUR FIELD ENGINEER AND THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE SYSTEM PERFORMED ACCORDING TO SPECIFICATIONS.
Description of Event or Problem · 1
THE PHYSICIAN REPORTED THAT THE MACHINE STOPPED IRRIGATING DURING THE PROCEDURE RESULTING IN THE PT GETTING A CORNEAL BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILLENNIUM MICROSURGICAL SYSTEM | MILLENNIUM MICROSURGICAL SYSTEM | HQC | BAUSCH + LOMB | CX1310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |