| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00917-1 |
| Product Name/Description |
Stellaris PC Vision Enhancement System (Cataract Extraction/Vitrectomy System)
Multiple serial numbers
ARTG Number: 127264 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
Bausch & Lomb recently determined that posterior fluidics modules (PFMs) installed in the Stellaris PC Vision Enhancement Systems listed may need to be recalibrated. These modules, which regulated the performance of the vitrectomy probe, may exhibit behaviour that could result in less efficient aspiration. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bausch & Lomb is providing work around instructions to mitigate the issue and will be replacing the posterior fluidics module to correct the problem. |
| Contact Information |
02 9390 1882 - Bausch & Lomb Australia |