FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3231989
·
Received July 15, 2013
Report
- Report Number
- 2028159-2013-01251
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Date of Event
- June 11, 2013
- Report Date
- June 17, 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS. A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT EXCESSIVE BUBBLES CAME INTO THE PT'S EYE IN THE MIDDLE OF A VITRECTOMY PROCEDURE. THE SURGEON FINISHED THE PROCEDURE WITH THE SAME EQUIPMENT, AND KEPT ASPIRATING THE BUBBLES OUT. THERE WAS NO HARM TO THE PT. THIS IS THE FIRST OF TWO MEDICAL DEVICE REPORTS FOR THIS FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327669 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | LXT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TOTAL PLUS PAK 25+ 5.0 CPM STD |