FDA clears Carl Zeiss Meditec's excimer laser system

The FDA cleared Carl Zeiss Meditec’s MEL 80 excimer laser system for vision correction eye surgery. The company is currently finalizing preparations for the commercial launch of MEL 80.

Clinical studies found that 93% of patients were corrected to 20/20 or better at 3 months, and 41% had correction to 20/12.5 or better at 6 months. The studies also found that 85% of patients saw within 0.5 D (optical power measurement) of the intended correction at 3 months.

“The FDA clearance of the MEL 80 for myopic correction is a major milestone achievement in our overall business strategy,” said Carl Zeiss Meditec AG President and CEO Ulrich Krauss.

Jim Taylor, president and CEO of Carl Zeiss Meditec Inc., added, “In addition to the excimer laser platform offered by our MEL 80, we have also pursued the development of an advanced femtosecond laser system for flap creation. The ongoing clinical testing of these femtosecond technologies has been both more rapid and more promising than we had anticipated, and a 510k has recently been filed. As a result, our intent is to bring a truly unique and comprehensive offering to our customers. In the United States, we are preparing an integrated launch of these products.”