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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 Carl Zeiss Pty Ltd
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