| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00120-1 |
| Product Name/Description |
AMO Tecnis CL Foldable Silicone IOL (Intraocular lens) with OptiEdge Design (Intraocular lenses indicated for primary implantation for the visual correction of aphakia in adults)
Model Number: Z9002
Serial Number: 1231181309
ARTG Number: 170331 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Medical Optics is issuing this Hazard Alert because certain Silicone Tecnis IOL s may have been labelled with the incorrect diopter power. A mislabelled IOL could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention to correct the issue. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
AMO Australia is providing the implanting surgeon with advice on the treatment of the patient implanted with the affected unit. |
| Contact Information |
1800 266 111 - Abbott Medical Optics |