| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00395-1 |
| Product Name/Description |
Centurion FMS Cassettes in Alcon Custom Paks
Product Code: 100306184
Catalogue Code: AS18573
Lot number: 16D1L8
ARTG 370933
(Alcon Laboratories Australia Pty Ltd - Surgical procedure kit, ophthalmic, non-medicated, single-use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
The affected Centurion FMS Cassettes fail to prime when used with the Centurion Vision System and cannot be used. The console will show an error message and be placed into a clinically inactive “safe state” which prevents the user from proceeding with preparation for surgery.
Alcon detected an increase in complaints of priming issues related to Centurion FMS cassette. Investigation identified a production error which caused a portion of cassettes from the affected batches to be non-functional.
The admin and I/A tubing were reversed during assembly. The error is limited to a portion of specific lots of Centurion FMS Cassettes assembled on a single production day by a single operator and does not affect all cassettes within the identified lots. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Upon opening the affected Custom Pak for surgical use, the FMS cassette should be removed and disposed of, allowing the remaining components of the Custom Pak to be used for their intended surgical procedure with a separate FMS cassette either from the customer's own inventory or that supplied by Alcon.
Alcon Custom Pak units are sterile and should not be opened prior to surgery. The remaining components of the Alcon Custom Pak are unaffected by this Product Defect Correction and can be used as intended.
This action has been finalised on 16/8/2024. |
| Contact Information |
1800 224 153 - Surgical Customer Services |