FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3022947
·
Received March 20, 2013
Report
- Report Number
- 2028159-2013-00473
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- February 21, 2013
- Report Date
- February 21, 2013
- Manufacturer
- ALCON -IRVINE TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT AIR CAME FROM THE AUTO STOPCOCK DURING A VITRECTOMY PROCEDURE. THEY OPENED ANOTHER PACK AND EXCHANGED ONLY THE INFUSION LINE, BUT A SMALL AMOUNT OF AIR STILL CAME IN. THE CASE WAS ABLE TO BE COMPLETED WITH NO IMPACT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116217 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON -IRVINE TECHNOLOGY CTR | LXT-JAPAN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TOTAL PLUS PAK 25+ 5.0 CPM VALVED STD J |