FDA Adverse Event
Malfunction
Summary report: N
ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM
MDR report key: 2081154
·
Received April 14, 2011
Report
- Report Number
- 2028159-2011-00369
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 15, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- MPA
- PMA / PMN Number
- K951627
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- 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
AN OPHTHALMIC MANAGER REPORTED THAT THE SYSTEM CONTINUES TO DISPLAY A SYSTEM MESSAGE THAT INDICATES LAMP FAILURE DESPITE THE LAMP MODULE BEING REPLACED TWICE. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM | ENDOILLUMINATOR | MPA | ALCON - IRVINE TECHNOLOGY CENTER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |