FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3040393
·
Received April 3, 2013
Report
- Report Number
- 2028159-2013-00588
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- March 4, 2013
- Report Date
- March 7, 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
- 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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT AIR CAME FROM THE AUTO STOPCOCK VALVE WHEN INFUSION WAS ON AND ENTERED THE PATIENT'S EYE. AS A RESULT, THE SURGEON'S SURGICAL VIEW WAS AFFECTED. THE CUSTOMER TROUBLESHOT BY CLAMPING THE IRRIGATION LINE AND WHEN THEY RELEASED IT AGAIN, AIR WAS DRAWN INTO THE IRRIGATION LINE. THE PROBLEM WAS SOLVED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136559 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON-IRVINE TECHNOLOGY CENTER | T-JAPAN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | TOTAL PLUS PAK| 25+ 5.0 CPM VALVED STD J |