FDA Adverse Event
Malfunction
Summary report: N
STELLARIS MICROSURGICAL SYSTEM
MDR report key: 3853834
·
Received April 18, 2014
Report
- Report Number
- 1920664-2014-00057
- Event Type
- Malfunction
- Date Received
- April 18, 2014
- Date of Event
- March 18, 2014
- Report Date
- March 18, 2014
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQC
- PMA / PMN Number
- K063331
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO SERVICE WAS REQUESTED BY THE USER FACILITY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.
Description of Event or Problem · 1
A REPORT WAS RECEIVED FROM A USER FACILITY IN THE USA STATING IT WAS OBSERVED THAT THE PHYSICIAN CAME CLOSE TO THE IRIS OF THE EYE DURING PHACOEMULSIFICATION. AFTER THE PROCEDURE WAS COMPLETED THE SURGEON REPORTED EXPERIENCING A "POST-OCCLUSION SURGE" WHICH HE ATTRIBUTED TO THE STELLARIS SYSTEM. THERE WAS NO PATIENT INJURY RELATED TO THE EVENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238910 | STELLARIS MICROSURGICAL SYSTEM | HQC | BAUSCH & LOMB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |