| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01070-1 |
| Product Name/Description |
IOLMaster (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 |
17/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
The ULIB database delivered with new devices as well as the ULIB database offered between March 25 and September 24, 2013 for download contained an erroneous value for one lens. This could lead to the implantation of a lens with a wrong diopter value. Specially the a0 constant of the lens AMO Sensar AR40E is listed as 0.0 in the internal lens database of the IOLMaster. The correct value is -2.420. The a0 value is only relevant if the Haigis-Formula or Haigis-L-Formula are used. Therefore, users that use the AMO Sensar AR40E and one of the two Haigis formulas are affected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Carl Zeiss is providing users with instructions on how to correct the a0 constant of the AMO Sensar AR40E on the affected IOLMaster systems and instructions on how to download the corrected database. |
| Contact Information |
1300 365 470 - Carl Zeiss Ophthalmic Systems |