| TGA Action ID |
RC-2025-RN-00445-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Alcon Constellation Pak
Multiple product identifiers
Expiry dates: 31/10/2026, 30/11/2026, 31/12/2026, 31/01/2027, 28/02/2027 & 31/03/2027 |
| ARTG Number |
145666 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is the potential that the Tyvek cover of some units within specific lots were damaged during the manufacturing process. Due to the risk of the Constellation Paks sterility being compromised, Alcon is recalling potentially affected lots.
The use of non-sterile surgical products may increase the risk of post-operative infection. To date, no customer complaints or adverse events have been reported due to this problem. |
| Instructions for Customers/Users |
Customers are advised to:
- Check their existing inventory immediately to confirm if they have the affected lot numbers.
- Segregate any unused affected product from your inventory.
- Clearly label the identified product with “Alcon Recall – MA 2025.007” and return to Alcon
To prevent an immediate shortage and the risk of cancelling emergency posterior segment surgeries, Alcon will inspect their remaining inventory of affected Constellation Paks. In the future, customers may receive shipments of identified lots that have been inspected. The re-inspected packs will be marked with a green indicator sticker with ‘QC PASSED’, to visually distinguish them from packs distributed prior to the recall initiation. The green sticker indicates the Constellation Pak has been re-inspected and confirmed to be undamaged and safe for use.
This action has been closed out on 31/03/2026 |
| Action Commencement Date |
12/05/2025 |
| Responsible Entity |
|
| Contact Information |
1800 224 153 - Alcon customer service |