FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 1940131
·
Received December 22, 2010
Report
- Report Number
- 2028159-2010-02477
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- November 1, 2010
- Report Date
- December 3, 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
- FR
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLES ARE EXPECTED FOR THIS COMPLAINT. THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF 06-DEC-2009 THROUGH 06-DEC-2010; THIS IS ONE OF TWO COMPLAINTS REPORTED FOR THIS ISSUE FOR THIS FACILITY. 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
A NURSE REPORTED THAT DURING SURGERY, THE ASPIRATION STOPPED WORKING. THE CASSETTE WAS REPLACED AND THE SURGEON WAS ABLE TO COMPLETE THE CASE. THERE WAS NO HARM TO THE PT REPORTED. ADD'L INFO HAS BEEN REQUESTED.
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 | NI |