FDA Clearance for Lensar Laser System

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Lensar's medical device, a laser system for making arcuate incisions on the periphery of the cornea during cataract surgery.

Providing precise capsulotomy incision size, shape, and location, the device enhances effective IOL lens positioning and fitting for each individual patient.

The device features the company's augmented reality technology, comprising of a proprietary high-resolution imaging and measurement technology to provide precise biometric information and 3D reconstruction of the anterior anatomy of the eye.

The technology also provides low noise images with high-contrast and resolution from the anterior surface of the cornea to the posterior capsule of the crystalline lens, even if dense cataracts are present.

Lensar medical advisory board member Dr Louis 'Skip' Nichamin says until recently, arcuate incisions in the cornea were made manually, which was leading to variability in predictable outcomes.

"Lensar's advanced technology platform will help cataract surgeons achieve consistent, predictable arcuate incision outcomes, regardless of the challenges and complexity of the procedure," Nichamin states. "With this latest clearance from FDA, Lensar is once again reaffirming its commitment to meeting all of the rapidly evolving needs of the cataract surgeon community."

The laser system's phacofragmentation techniques also provide surgeons with advantages in more efficient removal of all grades of cataracts and a major reduction or complete elimination of the use of the ultrasound energy required in conventional cataract surgery, according to the company.

The system, which is available in Europe and several other countries, has also been cleared for use in corneal incisions, as well as lens fragmentation and anterior capsulotomy (with or without phacofragmentation) during cataract surgery.

Lensar Chief Executive Officer, Nick Curtis, states; "Milestones of this type underpin the significant traction that we have experienced in rapidly accelerating the adoption of the Lensar platform among cataract surgeons around the world."