FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION WITH LASER
MDR report key: 1231085
·
Received October 30, 2008
Report
- Report Number
- 2028159-2008-00391
- Event Type
- Malfunction
- Date Received
- October 30, 2008
- Date of Event
- September 30, 2008
- Report Date
- September 30, 2008
- 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
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE RETURNED FOR EVAL. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION.
Description of Event or Problem · 1
THE SURGEON REPORTED, HE NEEDED TO REPLACE THE TROCAR DUE TO THE VITRECTOMY PROBE AND STRAIGHT ILLUMINATOR LIGHT PIPE INSTRUMENTS "STICKING" TO THE TROCAR INNER DIAMETERS. THE TROCAR WAS REPLACED AND THE CASE WAS COMPLETED AS PLANNED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTELLATION WITH LASER | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | CONSTELLATION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |