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Ingeneus wins TGA and CE manufacturing approval for cataract surgery device
17th September 2012
Ingeneus is pleased to announce that it has been granted both TGA and CE approval to manufacture the Torix™ Disposable Marking and Alignment System.
The single use device is used by ophthalmic surgeons to accurately align toric intra-ocular lenses (IOLs) at cataract surgery when patients also have significant corneal astigmatism.
Ingeneus worked with an Australian specialist cataract surgeon who invented the system, to prepare the regulatory information for submission of the device to the European and Australian Regulatory Authorities for approval. Ingeneus CEO Richard Walmsley said, “We are pleased to be working with Torix Pty Ltd, the company that is involved in the product, and to have assisted in gaining TGA and CE manufacturing approval for this important device. The Torix™ Disposable Marking and Alignment System will be available immediately for ophthalmic surgeons to use.”
“The device is the first sterile, disposable system available and will greatly assist ophthalmic surgeons to accurately align toric intra-ocular lenses. It consists of a pre-operative marker, handle and intra-operative axis guide.”
“Ingeneus will manufacture the device for Torix and as part of its manufacturing requirements Ingeneus has upgraded its ISO 13485 quality system to include the handling of sterile products.” Richard said.
The Torix™ Disposable Marking and Alignment System was launched at the European Society for Cataract and Refractive Surgery meeting in Milan during September 2012 and will be distributed by Designs for Vision in Australia and New Zealand.