FDA Adverse Event
Summary report: N
CONSTELLATION LXT
MDR report key: 3772188
·
Received April 9, 2014
Report
- Report Number
- 3772188
- Date Received
- April 9, 2014
- Date of Event
- March 23, 2014
- Report Date
- April 9, 2014
- Manufacturer
- ALCON
- Product Code
- HQC
- Report Source
- User Facility report
- Reporter Location
- KY, US
Narratives
Description of Event or Problem · 1
THE CONSTELLATION VITRECTOMY MACHINE STOPPED CUTTING, BUT CONTRIBUTED TO ASPIRATE RETINA INCARCERATED INTO CUTTER. DURING A LACERATION REPAIR OF THE RETINA, THE LACERATION THAT WAS ALREADY PRESENT GOT BIGGER. WE HAVE RETURNED MULTIPLE FLEX TIP RFID LASER PROBES WITH THIS MACHINE. RECENTLY, AN ALCON REP STATED A MANUFACTURING ISSUE. THE ILLUMINATED PROBES WILL NOT BE USED UNTIL ALCON ADDRESSES ISSUES WITH THIS DISPOSABLE PROBE. THE ALCON FIELD SERVICE REP REPLACED THE PNEUMATICS MODULE ON THE VITRECTOMY MACHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214735 | CONSTELLATION LXT | UNIT, PHACOFRAGMENTATION | HQC | ALCON | 812-4356-001 REUB | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | YES, THE DISPOSABLE 23G FLEX TIP RFID LASER PROBE,| ALCON, A NOVARTIS COMPANY |