FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 2093518
·
Received April 6, 2011
Report
- Report Number
- 2028159-2011-00355
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- January 24, 2011
- Report Date
- January 24, 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
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A NURSE REPORTED THAT THERE WAS POOR ASPIRATION DURING SURGERY. THE FLUID MANAGEMENT SYSTEM WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. NO PATIENT HARM WAS REPORTED.
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 |