FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3851933
·
Received April 11, 2014
Report
- Report Number
- 2028159-2014-00471
- Event Type
- Malfunction
- Date Received
- April 11, 2014
- Date of Event
- March 18, 2014
- Report Date
- March 18, 2014
- 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
A SAMPLE HAS BEEN SENT BY THE FACILITY BUT HAS NOT YET BEEN RECEIVED AT THE MANUFACTURING SITE. 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 CUSTOMER REPORTED THAT A SYSTEM MESSAGE WAS DISPLAYED WHEN CHANGING TO AIR SUBSTITUTION, WHICH DISCONTINUED IRRIGATION AND ASPIRATION. THE ISSUE WAS RESOLVED AFTER REBOOTING THE SYSTEM AND REPLACING THE CASSETTE. THE PROCEDURE WAS COMPLETED WITH NO IMPACT TO THE PATIENT. THE FACILITY ADVISED THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221372 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | LXT - JAPAN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TOTAL PLUS PAK 25 + 5.0 CPM VALVED STANDARD |