| TGA Action ID |
RC-2026-RN-00807-1 |
| Type of Product |
Biological |
| Product Name/Description |
Cornea for Endothelial Keratoplasty
Product Code: NCC74 |
| ARTG Number |
232298 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
NSW Tissue Bank has identified a problem affecting pre-cut corneal tissue supplied under product code NCC74 Cornea for Endothelial Keratoplasty. Interface fragments may be present within some DSAEK grafts due to a problem introduced during the post-production phase of preparing pre-cut organ culture corneas. Reports of retained interface fragments have been observed in a small number of transplant recipients.
To date, no adverse patient outcomes have been reported. |
| Instructions for Customers/Users |
Customers are to:
- Identify patients who have received affected NCC74 Cornea for Endothelial Keratoplasty grafts and complete the attached Customer Response Form during routine follow-up. |
| Action Commencement Date |
14/10/2026 |
| Responsible Entity |
|
| Contact Information |
02 9382 7855 - NSW Tissue Bank |