| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00757-1 |
| Product Name/Description |
LX3 Microscope Floor Stand used with the LuxOR Ophthalmic Microscope and LuxOR Ophthalmic Microscope with Q-VUE 3D Assistant Visualisation (used during ophthalmic surgical procedure for cataract, retina and cornea)
Product Code: 8065752560
ARTG Number: 210550 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
Alcon is undertaking a Recall for Product Correction of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message (4XX), and/or resulting in illumination failure. Alcon will retrofit the cable design on any impacted LX3 Microscope Floor Stands.
Loss of system functionality during surgery due to issues within the microscope modules or illumination failure will result in the loss of visualisation by the surgeon during the procedure, which can lead to the potential for patient injury. This could include scleral/corneal trauma, intraocular tissue damage, capsule injury, retinal tear/detachment, endothelial cell damage, corneal oedema or intraocular bleeding. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Alcon is retrofitting all affected devices with a new cable design. Alcon is recommending that if users choose to continue to use the affected devices before the correction has been performed, to ensure an alternative microscope and light source is available. This action has been closed-out on 17/08/2016. |
| Contact Information |
02 9452 9274 - QA Manager Alcon |