FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 3130349
·
Received May 22, 2013
Report
- Report Number
- 2028159-2013-00967
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 25, 2013
- 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
- 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED A FOOTSWITCH PROBLEM, SYSTEM MESSAGE CODE REC'D AND A CABLE NOT LOCKING INTO THE FOOTSWITCH DURING A PROCEDURE. NO PT HARM REPORTED. ADD'L INFO REQUESTED BUT NONE HAS BEEN REC'D.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226553 | INFINITI VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CTR | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ENHANCED FOOTSWITCH |