| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01146-1 |
| Product Name/Description |
Rayner T-Flex Aspheric 623T Intraocular Lens (Posterior chamber intraocular lenses)
Batch Numbers: 102E4206401, 102E4206402 & 102E4207001
ARTG Number: 100926 |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
The paper pouches used for packaging the Intraocular Lens have a deficiency which may result in sterility failure. The affected batches are under the control of the distributor are being recalled |
| Recall Action |
Recall |
| Recall Action Instructions |
The distributor has been asked to return all affected products to the sponsor, Kevin Grundy (IBD) Pty Ltd |
| Contact Information |
02 9261 0688 - Kevin Grundy |