FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3190683
·
Received June 24, 2013
Report
- Report Number
- 2028159-2013-01205
- Event Type
- Malfunction
- Date Received
- June 24, 2013
- Date of Event
- May 27, 2013
- Report Date
- May 28, 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 A SYSTEM MESSAGE DISPLAYED DURING A PROCEDURE AND THE CASE WAS COMPLETED WITHOUT IOP (INTRAOCULAR PRESSURE) CONTROL. IT WAS NOTED THAT THE PRIMING TEST HAD BEEN PASSED BEFORE SURGERY. THERE WAS NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285274 | 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 |