FDA Adverse Event
Injury
Summary report: N
MILLENNIUM MICROSURGICAL SYSTEM
MDR report key: 1030268
·
Received April 17, 2008
Report
- Report Number
- 1920664-2008-00472
- Event Type
- Injury
- Date Received
- April 17, 2008
- Date of Event
- March 18, 2008
- Report Date
- March 18, 2008
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQC
- PMA / PMN Number
- K961310
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE SURGEON HAD DIFFICULTY MAINTAINING THE CHAMBER DUE TO LOW ASPIRATION AND THE CAPSULE WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILLENNIUM MICROSURGICAL SYSTEM | OPHTHALMIC MICROSURGICAL UNIT | HQC | BAUSCH & LOMB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |