FDA Adverse Event
Injury
Summary report: N
CONTELLATION VISION SYSTEM
MDR report key: 3771005
·
Received December 18, 2013
Report
- Report Number
- 2028159-2013-02394
- Event Type
- Injury
- Date Received
- December 18, 2013
- Date of Event
- December 2, 2013
- Report Date
- December 2, 2013
- Manufacturer
- ALCON MANUFAC- IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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 IS AVAILABLE. (B)(4).
Description of Event or Problem · 1
A HEALTHCARE PROFESSIONAL REPORTED THAT SYSTEM MESSAGE WAS DISPLAYED DURING SURGERY INDICATING THAT THE REMOTE CONTROL BATTERY SHOULD BE CHANGED. SURGERY COULD NOT BE COMPLETED. DESPITE SEVERAL MANIPULATIONS, SYSTEM DID NOT TURN OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664021 | CONTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON MANUFAC- IRVINE TECHNOLOGY CENTER | WITH LASER | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |