FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 2081155
·
Received April 14, 2011
Report
- Report Number
- 2028159-2011-00378
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 15, 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
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE REPORTED EVENT OF NO PHACO IN QUAD MODE. NO SYSTEM MESSAGES WERE RECORDED IN THE EVENT LOG. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE ARE NO SAMPLES RETURNING FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THE EVENT, THEREFORE, STEPS CANNOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED DURING A PROCEDURE, THE UNIT WOULD NOT PHACO IN QUADRANT MODE. THE SYSTEM WAS EXCHANGED TO COMPLETE THE CASE. THERE WAS NO HARM OR INJURY TO THE PATIENT.
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 | PROVISC |