FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 2092166
·
Received April 27, 2011
Report
- Report Number
- 2028159-2011-00454
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 28, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K021566
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO REGARDING PRODUCT EVAL IS PENDING. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT WHILE ASPIRATING THE VISCOELASTIC OUT OF THE EYE, A SYSTEM MESSAGE WAS REC'D AND THE UNIT WAS LOCKED. THE SYSTEM WAS REBOOTED, THE CASSETTE WAS REPLACED, AND ATTEMPTS WERE MADE TO RE-PRIME AND RE-TUNE WHEN ANOTHER SYSTEM MESSAGE WAS DISPLAYED. THE SYSTEM WAS THEN SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS NO PT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |