FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3910048
·
Received February 25, 2014
Report
- Report Number
- 2028159-2014-00302
- Event Type
- Malfunction
- Date Received
- February 25, 2014
- Date of Event
- January 27, 2014
- Report Date
- January 27, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
HOSPITAL REPORTED THAT A SYSTEM MESSAGE WAS DISPLAYED DURING SURGERY LEADING THE SYSTEM TO WORK AT HALF POWER. THE SURGERY PROGRAM WAS NOT COMPLETED YET, AND THEY CONTINUED PERFORMING SURGERY ON THE PATIENTS. THERE WERE NO COMPLICATIONS DURING SURGERIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116750 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | LXT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |