FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 4133008
·
Received September 29, 2014
Report
- Report Number
- 2028159-2014-01786
- Event Type
- Malfunction
- Date Received
- September 29, 2014
- Date of Event
- September 2, 2014
- Report Date
- September 2, 2014
- 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
- IN, US
- Reporter Occupation
- UNKNOWN
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 THAT DURING THE PHACOEMULSIFICATION MODE OF A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THERE WAS CONTINUOUS IRRIGATION AFTER THE SURGEON TOOK HIS FOOT OFF THE FOOTSWITCH. IT WAS ALSO NOTED THE SCREEN AND THE FOOTSWITCH FROZE. THE PROCEDURE WAS COMPLETED WITHOUT HARM TO THE PT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606484 | INFINITI VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INFINITI ENHANCED FOOTSWITCH |