FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 2103412
·
Received May 17, 2011
Report
- Report Number
- 2028159-2011-00555
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- April 18, 2011
- Report Date
- April 18, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K082845
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE FOOTSWITCH INTERFACE PRINTED CIRCUIT BOARD (PCB), DC POWER CABLE, AND COMMUNICATION CABLE. THE SYSTEM WAS THEN TESTED MET PRODUCT SPECIFICATIONS. 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 DURING SURGERY, WHEN THE SETTINGS WERE CHANGED, A SYSTEM MESSAGE WAS DISPLAYED. THEY REBOOTED THE SYSTEM, BUT THE MESSAGE REMAINED. THE SYSTEM WAS EXCHANGED AND THE SURGERY WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |