FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYS OZIL
MDR report key: 3851654
·
Received April 18, 2014
Report
- Report Number
- 2028159-2014-00641
- Event Type
- Malfunction
- Date Received
- April 18, 2014
- Date of Event
- March 1, 2014
- Report Date
- March 24, 2014
- Manufacturer
- ALCON -IRVINE TECH CTR
- Product Code
- HQC
- PMA / PMN Number
- K021566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 REPORTED THAT THE REFLUX MODE WOULD NOT WORK ON THE FOOTPEDAL. THE PT INVOLVEMENT IS UNK AT THIS TIME. ADDITIONAL INFO HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238485 | INFINITI VISION SYS OZIL | PHACOFRAGMENTATION SYS | HQC | ALCON -IRVINE TECH CTR | INFINITI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | INFINITI ENHANCED FOOTSWITCH |