| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01065-1 |
| Product Name/Description |
IOLMaster 500, software version 7.5.2, 7.7.2 and 7.7.3
(used for the treatment of axial length, corneal curvature, anterior chamber depth and for the determination of the white-to-white distance (WTW) of the human eye, as well as for the calculation of the required intraocular lens)
ARTG Number: 128166 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
These versions of software have a software defect which can result in incorrect IOL calculations being presented on screen and in a printout/export in rare cases when a specific non-standard workflow is used. This could lead to order and implantation of IOLs with wrong lens power and to (correctable) impairment of patient's visual acuity. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To correct the software anomaly users are advised to perform the software update to version 7.5.3 or 7.7.4 using the USB stick by following the instructions provided in customer letter. This action has been closed-out on 31/08/2016. |
| Contact Information |
1300 365 470 - Carl Zeiss |