FDA Adverse Event
Malfunction
Summary report: N
ACCURUS 800CS
MDR report key: 2073701
·
Received April 13, 2011
Report
- Report Number
- 2028159-2011-00376
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 14, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K911808
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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 INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED DURING A PROCEDURE, THE PROBE WAS NOT CUTTING THE VITREOUS. THE PROBE WAS EXCHANGED TO COMPLETE THE CASE WITHOUT HARM OR INJURY TO THE PT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCURUS 800CS | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | ACCURUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |