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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 Alcon Laboratories Australia Pty Ltd
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