FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 4240320
·
Received October 29, 2014
Report
- Report Number
- 2028159-2014-02011
- Event Type
- Malfunction
- Date Received
- October 29, 2014
- Date of Event
- September 30, 2014
- Report Date
- September 30, 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT BEEN EVALUATED YET. 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 CUSTOMER REPORTED THAT THE SURGEON NOTICED LOW ASPIRATION DURING A CATARACT PROCEDURE. A PLASTIC MATERIAL WAS FOUND TO BE OBSTRUCTING THE FLUIDICS MANAGEMENT SYSTEMS TUBING. THE ISSUE WAS RESOLVED THROUGH PRODUCT REPLACEMENT. THERE WAS NO REPORT OF HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 691425 | INFINITI VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ULTRASOUND FLUIDICS MANAGEMENT SYSTEM -| 30 KELMAN PACK| MICRO SLEEVE| TAPARED ASPIRATION BYPASS SYSTEM |