06.18.18

Bausch + Lomb Receives FDA Premarket Approval for Envista Toric MX60T IOL

Source: Bausch + Lomb

Bausch + Lomb announced that it has received premarket approval (PMA) from the FDA for the enVista toric MX60T, the company’s first hydrophobic acrylic IOL for astigmatism correction.

The enVista toric MX60T IOL features a one-piece aberration-free, aspheric optic with fenestrated, step-vaulted, modified C-loop haptic design that delivers exceptional rotational stability and ensures predictable astigmatism correction. Additionally, the optic’s posterior square edge provides a 360 degree barrier to posterior capsular opacification (PCO).

The enVista IOL material remains the only single-piece, hydrophobic acrylic material domestically available that have been proven to be glistening-free, according to Bausch + Lomb. The enVista material also has the potential for increased resistance to scratches and abrasions that may occur during loading and surgical manipulation.

“Building on the proven features and benefits of the enVista family of IOLs, MX60T represents another innovation in the continued expansion of this lens platform,” Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb, said in the news release. “The addition of this new lens to our portfolio offers surgeons a wide range of IOLs with seven cylinder powers to meet their astigmatic patients’ needs.”

In a recent prospective, multicenter study designed to evaluate the safety and effectiveness of the enVista toric MX60T, the lens demonstrated 5° or less of absolute rotation in 100% of subjects.

“The rotational stability of a toric IOL is critical, as even the slightest rotation can lead to a decrease in the toric effect, compromising outcomes,” Mark Packer, medical monitor for the enVista toric MX60T study and ophthalmologist, Boulder, Colorado, said in the news release.  “The results of this study show that the enVista toric MX60T lens provides excellent rotational stability, astigmatism correction and uncorrected visual acuity. I look forward to this lens being available to astigmatic cataract patients who would benefit from this technology based on the wonderful results I observed during the clinical study.”

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