| TGA Action ID |
RC-2025-RN-00446-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Alcon Custom-Pak
Multiple product identifiers |
| ARTG Number |
370933 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is a potential for the Tyvek cover of certain units in specific lots of Alcon Constellation Pak to have been damaged during the manufacturing process. All components inside the Custom Pak, including the Constellation Pak, which may have damaged Tyvek cover, are sterile as part of the terminal sterilisation process for Custom Pak.
The affected Custom Pak can be continued to be used for surgery. However, Alcon is advising that after an affected Custom Pak is opened in a sterile environment (i.e. surgical field), the affected Constellation Pak be used for that specific surgical case and discarded at the end of the surgical case.
If the Constellation Pak was not used for the surgery, it should not be saved for future use. Each component is intended to be used only on the specific surgical case for which the Custom Pak is opened and should be discarded at the end of the surgical case. |
| Instructions for Customers/Users |
· Customers are advised that they should check existing inventory to determine if the lot number(s) are affected. If affected inventory is identified, a copy of this letter should be displayed in close vicinity to the products.
· Customers are advised that all components within the Custom Pak, including the Constellation Pak, are sterile due to terminal sterilisation. Affected Custom Pak may continue to be used; however, once an affected Custom Pak is opened, the Constellation Pak within it should be used solely for that specific surgical case and discarded at the end of the case. The Constellation Pak must not be retained for future use, as each component is intended for single-case application only.
· Customers are advised that if any Alcon Constellation Pak from affected Custom Pak lots have been re-shelved, these should be removed from inventory and disposed of in designated medical waste bins.
This action has been closed out on 01/04/2026 |
| Action Commencement Date |
9/05/2025 |
| Responsible Entity |
|
| Contact Information |
02 9452 9382 - Prajakta Vartak |