FDA Adverse Event
Malfunction
Summary report: N
LAUREATE WORLD PHACO SYSTEM
MDR report key: 1221555
·
Received November 5, 2008
Report
- Report Number
- 2028159-2008-00400
- Event Type
- Malfunction
- Date Received
- November 5, 2008
- Date of Event
- October 6, 2008
- Report Date
- October 6, 2008
- Manufacturer
- ALCON- IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K021566
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE FLUIDICS MODULE. THE FLUIDICS MODULE WILL BE SENT FOR IN HOUSE TESTING. 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 INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
THE SURGEON REPORTED THAT THE SYSTEM DISPLAYED TWO SYSTEM MESSAGES DURING SET UP. THREE CASES WERE CANCELLED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAUREATE WORLD PHACO SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON- IRVINE TECHNOLOGY CENTER | LAUREATE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |