FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION
MDR report key: 1834399
·
Received September 10, 2010
Report
- Report Number
- 2028159-2010-01716
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Date of Event
- August 6, 2010
- Report Date
- August 11, 2010
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K063583
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
ADVERSE EVENT(S): "NO PT HARM" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "LEAKY CASSETTE" (FLUID LEAK). CUSTOMER REPORTED THAT DURING A PROCEDURE, THE CASSETTE WAS LEAKY. NO SYSTEM MESSAGE WAS DISPLAYED. THE SURGERY WAS COMPLETED WITHOUT DELAY AND THERE WAS NO PT HARM WAS REPORTED. ADDITIONAL INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTELLATION | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | CONSTELLATION | 1011744H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONSTELLATION SURGICAL PAK |