| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00726-1 |
| Product Name/Description |
Pentacam AXL (Type 70100) and Pentacam AXL Wave (Type 70020)
Serial numbers: 70020 0731 2290, 70020 9731 2290, 70020 7041 2221 and 70020 9631 2290
ARTG 175820
(Designs for Vision Aust Pty Ltd - Corneal topography system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/08/2023 |
| Responsible Entity |
|
| Reason/Issue |
One of the suppliers did not meet the specifications for an optical component inside the devices. An insufficient anti-reflective coating was found, which under certain circumstances can lead to an additional axial length signal. If the correct axial length signal is weaker (e.g. due to an off-centre measurement or a cataract), an incorrect axial length value can be displayed. OCULUS identified the problem within the production process.
There have been no reports of physical injury or serious negative consequences. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to Immediately stop using the affected device for axial length measurement. Mark the affected device with a note or take out of service.
OCULUS will replace or repair the affected devices. A representative will contact customers to coordinate the further procedure (such as exchange, repair, supply of loan devices).
This action has been closed out on 07/12/2023 |
| Contact Information |
1800 225 307 - Designs for Vision |