FDA Clears Laser System for Use in Cataract Surgery

Yael Waknine

May 26, 2010

May 26, 2010 — The US Food and Drug Administration (FDA) has approved a laser system (LensAR; LensAR, Inc) for anterior capsulotomy during cataract surgery.

The system integrates the company's proprietary 3-dimensional laser scanning and ocular measurement technologies with an advanced tissue cutting laser designed to deliver precise surgical incisions that are currently performed manually.

FDA approval was backed by clinical data from a study performed at the APEC Hospital in Mexico City, showing that laser capsulotomies are significantly more precise than manual capsulorhexis in intended vs achieved diameter and in circularity.

"The capsulotomy is arguably the most critical and precise step in cataract surgery and the ability to improve its sizing, centration, and consistency through automation is an important and exciting advance," stated David F. Chang, MD, LensAR medical monitor, in a company news release.

According to Medical Advisory Board member Louis D. "Skip" Nichamin, MD, the system's increased precision can enhance surgical outcomes while assisting both experienced and inexperienced surgeons in achieving more consistent results.