FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 2854756
·
Received November 30, 2012
Report
- Report Number
- 2028159-2012-01893
- Event Type
- Malfunction
- Date Received
- November 30, 2012
- Date of Event
- November 1, 2012
- Report Date
- November 2, 2012
- 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
- NC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP EXAMINED THE SYS AND FOUND THE TOUCHSCREEN WAS NOT WORKING. THE TOUCHSCREEN WAS REPLACED. THE SOFTWARE WAS UPDATED. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE TOUCHSCREEN HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. (B)(4).
Description of Event or Problem · 1
A NURSE REPORTED THAT THE TOUCHSCREEN WAS WORKING ERRATICALLY DURING A SURGICAL PROCEDURE. FOLLOWING A FIVE MIN DELAY, THE SYSTEM WAS SWITCHED OUT AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.
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 |