| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00613-1 |
| Product Name/Description |
Centurion FMS (Fluidics Management System) Pack (used to control irrigation and aspiration in the eye during cataract surgery)
Catalogue Numbers: 8065752180, 8065752181, 8065752200, 8065752201, 8065752917, 8065752918
Lot Numbers: 1794105H, 1801726H, 1804659H, 1802316H, 1794157H, 1802311H, 1801714H
ARTG Number: 145666 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
Alcon is conducting a recall for specific lots and catalogue numbers of its CENTURION FMS (Fluidics Management System) Pack due to the possible presence of a moulding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line. The use of products from the affected lots may result in a small air leak and corresponding reduction in vacuum performance, leading to inability to achieve or reach maximum targeted vacuum and reduction of holding force at the distal end of the phaco tip.
There is a risk of thermal injury, capsular bag tear, tissue damage, corneal endothelial cell damage, corneal oedema, retinal tear/detachment, and endophthalmitis. There have been no reports of injuries associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Alcon is advising users to review inventory and stop using the affected product for replacement with unaffected product.
This action has been closed out on 08/11/2018 |
| Contact Information |
02 9452 9387 - Alcon Laboratories Regulatory Affairs |