| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00911-1 |
| Product Name/Description |
SIL-1000-S, SIL-2000-S, SIL-5000-S Silicone Oil - Prefilled 10ml syringes
All product lots distributed since October 2022
ARTG 408427
(Designs for Vision Aust Pty Ltd - Retinal tamponade medium, postoperative) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
A risk has been identified associated with the handling of silicone oil injections when the pre-filled syringe is connected to a surgical system to perform injections during ophthalmic surgery. It has been determined that breakage of the syringe can occur during use when the injection pressure is elevated above 4.0 bar. A new instruction to the Instructions for Use (IFU) is being implemented to limit the injection pressure to a maximum of 4.0 bar during injection of silicone oil.
In the event the glass syringe breaks during the use of the silicon oil injection procedure, parts of the glass may injure the user or patient and lead to tissue damage with blood loss.
Seven reports of the silicone oil pre-filled syringe breakage have occurred in the past 12 months. There has been no patient or personnel harm reported as a result of these incidents.
|
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The IFU will be updated to include new instruction to limit the injection pressure to a maximum of 4.0 bar during injection of silicone oil.
Customers are to be aware of this update when using the device and attach the customer letter as an addendum to the IFU. |
| Contact Information |
recalls@paragoncare.com.au - Paragon Care |