| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00589-1 |
| Product Name/Description |
Tecnis CL Foldable Silicone IOL with OptiEdge Design
Model Number: Z9002
Multiple serial numbers affected
ARTG Number: 170331 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
Certain Silicone Tecnis IOLs may be labelled with the incorrect diopter power. Use of a mislabelled IOL could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention to correct. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abbott Medical Optical (AMO) is requesting their customers to remove affected devices from their inventory. Affected devices are to be returned to AMO and replacements provided. |
| Contact Information |
1800 266 111 - AMO Customer Service |