| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01151-1 |
| Product Name/Description |
TECNIS 1-Piece Intraocular Lens (IOL) with TECNIS iTEC Preloaded Delivery System PCB00
Serial Numbers: 7138311403 and 7139121403
ARTG Number: 203780 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has become aware of a small number of TECNIS 1-Piece IOLs (two in Australia) that may have been mislabelled with the wrong diopter power. This is due to an inspection equipment malfunction during manufacturing. There is potential for lenses to have out of specification diopter or resolution. Use of a mislabelled IOL could lead to potential unexpected post-operative refractive error. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Abbott are advising surgeons that if there were no issues identified during routine post-operative follow up, no further action is required regarding the implanted IOL. This action has been closed-out on 12/05/2017. |
| Contact Information |
02 9855 0118 - Aboott Vision |