FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 1840062
·
Received September 15, 2010
Report
- Report Number
- 2028159-2010-01732
- Event Type
- Malfunction
- Date Received
- September 15, 2010
- Date of Event
- August 13, 2010
- Report Date
- August 16, 2010
- 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
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
ADVERSE EVENT(S): "NO PT INVOLVED" (NO PT INVOLVEMENT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE. THE NURSE REPORTED THE SYSTEM WOULD NOT TUNE THE HANDPIECE AND A SYSTEM MESSAGE DISPLAYED. THE HANDPIECE WAS SWITCHED OUT WITH THE SAME RESULT. THE SYSTEM WAS SWITCHED OUT AND THE CASE PROCEEDED. NO PT WAS INVOLVED
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 | UNK |