Carl Zeiss Meditec’s MEL 80 Excimer Laser Receives FDA Approval

Carl Zeiss Meditec, a leading global medical technology supplier, has received the U.S. Food and Drug Administration’s (FDA) premarket approval for its MEL 80 Excimer Laser for treatment of hyperopia. The FDA had previously approved the laser for treatment of astigmatism and myopia.

Hyperopia or farsightedness causes difficulty in focusing on near objects. FDA has added the MEL 80 Excimer Laser in the primaryLaser Assisted in situ Keratomileusis (LASIK) treatments to reduce or eliminate hyperopia that occurs naturally in patients who are aged 21 years and above. The MEL 80 can be used to treat hyperopia that is equal to or less than +5.0 D and has a maximum MRSE of +5.0 D. The condition may or may not include a refractive astigmatism of > +0.5 D and < +3.0.

Carl Zeiss Meditec had conducted the MEL 80 study on 189 patients. After a year, 96.7% of the patients had demonstrated 20/40 or more of uncorrected visual acuity. The study results were presented at the American Society of Cataract and Refractive Surgery’s annual meeting held in San Diego on the 27^th of March.