FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3190754
·
Received June 24, 2013
Report
- Report Number
- 2028159-2013-01252
- Event Type
- Malfunction
- Date Received
- June 24, 2013
- Date of Event
- May 27, 2013
- Report Date
- May 27, 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 PRIOR TO A RETINA PROCEDURE, THE SYSTEM DISPLAYED AN ADVISORY INDICATING TO EJECT AND REINSERT THE CASSETTE. ALSO, THAT DURING THE SURGERY, THE INTRAOCULAR PRESSURE CONTROL REPEATEDLY WAS SWITCHING ON AND OFF. THERE WAS NO PT HARM REPORTED AND THE PROCEDURE WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286417 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | LXT-JAPAN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 G COMPLETE CUSTOM PAK |