| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00751-1 |
| Product Name/Description |
Alcon 23 Gauge and 25 Gauge Valved entry systems
(cannulas designed to allow entry of instruments to the back of the eye during ophthalmic surgery)
Valved Entry Systems sold as standalone and contained within CONSTELLATION TOTALPLUS Paks and Alcon CUSTOM-PAKS
Product Numbers:
8065 751 585, 8065 751 586, 8065 751 657, 8065 751 658, 8065 751 900, 8065 751 902, 8065 751 908, 8065 751 910
ARTG Number: 148011 and 145666 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that a small percentage of the single-use 23 Gauge and 25 Gauge Valved entry systems have the potential to leak beyond their design specification. Leakage of fluid during ophthalmic surgery can lead to fluctuations of intraocular pressure (IOP) in patients. The occurrence of a leaking valved cannula is easily detectable to the user intra-operatively as there will be visible leaking of fluid/saline solution from the entry point of the cannula prior to performing surgery. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To prevent fluctuations of IOP during surgery, surgeons can use the Constellation Vision System’s IOP control feature. Alternatively a plug can be inserted the valve entry system. Alcon is providing standalone plugs to be inserted into affected valve entry systems in the event that unwanted leakage is detected. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 224 153 - Alcon Customer Service |