FDA Adverse Event
Malfunction
Summary report: N
SERIES 20000 LEGACY
MDR report key: 2030888
·
Received March 4, 2011
Report
- Report Number
- 2028159-2011-00202
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 9, 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THERE WAS FLUID LEAKING FROM THE CASSETTE DURING A PROCEDURE. THE CASSETTE WAS EXCHANGED, BUT THE LEAKAGE PERSISTED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES 20000 LEGACY | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | STTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |