FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 3070635
·
Received April 17, 2013
Report
- Report Number
- 2028159-2013-00715
- Event Type
- Malfunction
- Date Received
- April 17, 2013
- Report Date
- March 22, 2013
- 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
- BE
- Reporter Occupation
- OTHER
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 SURGEON REPORTED TO A COMPANY SALES REPRESENTATIVE THAT THERE WAS A KINK IN THE CASSETTE'S TUBING ON THE JUNCTION WITH THE HANDPIECE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE KINK WAS NOTED DURING THE IRRIGATION/ASPIRATION STEP OF THE PROCEDURE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH NO DIFFICULTIES. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 166393 | INFINITI VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INTREPID PLUS BASIC PAK| CUSTOM PAK |