FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3221888
·
Received July 9, 2013
Report
- Report Number
- 2028159-2013-01351
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- February 14, 2013
- Report Date
- June 13, 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. A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT AIR WAS FOUND IN THE INFUSION LINE DURING THE SURGERY. THE PROBLEM WAS RESOLVED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313542 | 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 STD J |