| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01205-1 |
| Product Name/Description |
Stellaris PC with Laser System (Cataract extraction/vitrectomy system)
Product Code: BL14304
Serial Number : SPC02059
ARTG Number: 127264 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
The Stellaris PC has a software fault, when in surgery, if the surgeon requests a Laser sub-mode change (i.e. from Endo to Endo Continuous) and the system is in “Standby”, the system will automatically transition from “Standby” to “Ready” to fire. If the system moves to Ready from Standby, and this has not been specifically commanded by the Surgeon or the Nurse, it raises the possibility that this change may not have been noticed and that the foot pedal could be depressed and the laser may fire unexpectedly. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bausch and Lomb has developed a software update to address the situation, which will be installed in the affected system. In the meantime, users may continue to use the Stellaris PC laser system. However, they are advised not to request the Laser sub-mode change from Endo to Endo Continuous during surgery until the software update has been implemented. This action has been closed-out on 06/06/2016. |
| Contact Information |
02 8918 6216 - Bausch and Lomb Regulatory Affairs |