FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 1941681
·
Received December 10, 2010
Report
- Report Number
- 2028159-2010-02342
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- November 11, 2010
- Report Date
- November 10, 2010
- 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
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE SURGEON REPORTED THAT IRRIGATION CONTINUED TO FLOW EVEN WHEN FOOT PEDAL WAS RELEASED. A PT WAS INVOLVED, BUT NO INJURY WAS REPORTED. ADD'L INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI | 1071846H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INFINITI SURGICAL PAK |