FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3112031
·
Received May 7, 2013
Report
- Report Number
- 2028159-2013-00865
- Event Type
- Malfunction
- Date Received
- May 7, 2013
- Date of Event
- March 29, 2013
- Report Date
- April 10, 2013
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS. A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT A GIANT AIR BUBBLE CAME OUT OF THE INFUSION LINE DURING A VITRECTOMY PROCEDURE. IT WAS ALSO REPORTED THAT BUBBLES ENTERED THE VITREOUS CAVITY AND OBSTRUCTED THE SURGEON'S VIEW OF THE EYE. THE SURGEON ATTEMPTED TO REMOVE THE AIR BUBBLES USING THE VITRECTOMY PROBE, HOWEVER THE ISSUE DID NOT RESOLVE AS THE BUBBLES WERE STREAMING FROM THE INFUSION CANNULA. THE SURGEON REPLACED THE INFUSION LINE AND THE CASE WAS COMPLETED WITHOUT HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 199883 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | TABLETOP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | COMBINED PROCEDURE PAK, 20+ 5.0 CPM 0.9 |