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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 Bausch & Lomb Australia Pty Ltd
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