FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 1695532
·
Received April 30, 2010
Report
- Report Number
- 2028159-2010-00568
- Event Type
- Malfunction
- Date Received
- April 30, 2010
- Report Date
- April 1, 2010
- Manufacturer
- ALCON - IRVINCE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K082845
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE FOOTSWITCH HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. 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
ADVERSE EVENT(S): "THERE WAS A 10 MINUTE DELAY" (SURGICAL PROCEDURE, DELAYED). PRODUCT PROBLEM(S): "POOR REFLUX DURING SURGERY" (REFLUX WITHIN DEVICE). THE NURSE REPORTED POOR REFLUX DURING SURGERY. THE SYSTEM AND FOOTSWITCH WERE SWITCHED OUT TO COMPLETE THE CASE. THERE WAS A 10 MINUTE DELAY. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINCE TECHNOLOGY CENTER | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |