FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION WITH LASER
MDR report key: 2043056
·
Received March 25, 2011
Report
- Report Number
- 2028159-2011-00300
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- February 23, 2011
- Report Date
- February 25, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K063583
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS. A SAMPLE HAS BEEN RETURNED, BUT HAS NOT YET BEEN EVALUATED. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THE SYSTEM STOPPED ASPIRATING FLUID FROM THE EYE, DESPITE THE PEDAL BEING FULLY DEPRESSED, WHILE ON CONTINUOUS PHACO MODE. A NEW CASSETTE WAS INSERTED AND THE CASE WAS COMPLETED WITH NO FURTHER INCIDENTS. THERE WAS NO PT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTELLATION WITH LASER | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | CONSTELLATION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |