FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 1992845
·
Received February 4, 2011
Report
- Report Number
- 2028159-2011-00082
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 4, 2011
- Report Date
- January 7, 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
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP EXAMINED THE SYSTEM AND FOUND SYSTEM MESSAGES RELATED TO PHACO AND SUCTION IN THE EVENT LOG. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REPLACEMENT FOOTSWITCH AND CABLE WERE PROVIDED TO THE CUSTOMER. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).
Description of Event or Problem · 1
THE SURGEON REPORTED DURING A PROCEDURE THE FOOT PEDAL DID NOT RESPOND TO HIS DIRECTION AND THERE WAS AN ISSUE WITH SUCTION. THE SURGERY WAS COMPLETED THE SAME DAY. ADDITIONAL INFO HAS BEEN REQUESTED.
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 |