FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYS OZIL
MDR report key: 4173182
·
Received October 10, 2014
Report
- Report Number
- 2028159-2014-01874
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- September 9, 2014
- Report Date
- September 9, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K082845
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED NO PHACO POWER OR VACUUM DURING CATARACT SURGERY. THE SYS WAS SWITCHED OUT TO COMPLETE THE CASE. THERE WAS NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642703 | INFINITI VISION SYS OZIL | PHACOFRAGMENTATION SYS | HQC | ALCON - IRVINE TECHNOLOGY CTR | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |