Submitted by administrator on
Following its approval by the FDA in the USA, the Catalys Precision Laser System which offers improved a vastly laser cataract removal system, has been awarded the Conformité Européenne, or more commonly recognised CE marking. This CE marking approves the system for creating single-plane and multi-plane arc cuts/incisions in the cornea during cataract surgery. This new recognition will allow for a further optimised experience for patients with cataracts as well as offering a better option for the surgeons performing the said eye operation.
The CE marking of a product, translated to European Conformity, allows an item to be used for desired purposes on the European market, ensuring that it is appropriate for its intended use and has been thoroughly checked to the required EC directives. Although the CE mark does not confirm the quality of this laser eye system, or any other product for that matter, the approval confirms to users that it complies with essential requirements laid out by Directive 93/42/EEC in regard to medical instruments and devices. It confirms that the unit is safe for purpose, in this case the removal of cataracts during eye surgery.
The corneal incisions application is available through an update to the Catalys systems software, and will be downloadable or purchased in the near future from the laser systems manufacturer, OptiMedica.
The Catalys system utilises a femtosecond laser for breakthrough precision and results in the removal of cataracts from the eye. This new technology offers cataract suffering patients a much safer technology to take advantage of as it decreases the amount of ultrasound energy that may be required in breaking down cataracts ready for extraction. The ophthalmic unit has been designed and deployed for cataract surgery, with an anticipation that it will be able to offer leaps in precision while also offering an easy to use and ergonomic system.