FDA Adverse Event
Malfunction
Summary report: N
SERIES 20000 LEGACY
MDR report key: 1834414
·
Received September 10, 2010
Report
- Report Number
- 2028159-2010-01736
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Date of Event
- August 10, 2010
- Report Date
- August 12, 2010
- 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
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. A REVISION AND PLATE CLEANING WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).
Description of Event or Problem · 1
ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "WHITE SCREEN" (NO DISPLAY OR DISPLAY FAILURE); "SHUT DOWN" (LOSS OF POWER). A CUSTOMER REPORTED THE SCREEN WENT WHITE THEN SHUT OFF COMPLETELY DURING A CASE. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES 20000 LEGACY | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |