FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISON SYSTEM OZIL
MDR report key: 3880549
·
Received April 9, 2014
Report
- Report Number
- 2028159-2014-00624
- Event Type
- Malfunction
- Date Received
- April 9, 2014
- Date of Event
- March 12, 2014
- Report Date
- March 12, 2014
- 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
- RI, US
- Reporter Occupation
- NURSE
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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A NURSE REPORTS THAT DURING THE MIDDLE OF A PROCEDURE, THE SYSTEM STOPPED WORKING. AFTER A FIFTEEN MINUTE DELAY, THE PROCEDURE WAS COMPLETED WITH THE SAME SYSTEM WITH NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214168 | INFINITI VISON SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |