FDA Approves New LASIK Device Teneo for Vision Correction Surgery

The FDA has approved Teneo Excimer Laser Platform (Bausch + Lomb Corporation), a new laser assistance in situ keratomileusis (LASIK), for vision correction surgery for those who have myopia and myopic astigmatism, known as nearsightedness or nearsightedness with astigmatism, according to a press release. Teneo offers unique features that have not been previously offered by excimer laser platforms.

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“Teneo has been well received and is widely adopted in more than 50 countries around the world, and now [United States] ophthalmologists will benefit from this versatile laser," Luc Bonnefoy, president of Global Surgical at Bausch + Lomb, said in the press release. “The precise engineering of this platform delivers a fast, small, technologically advanced machine that provides an exceptional experience for both surgeons and patients.”

According to the press release, Teneo has an advanced eye-tracker, operating at 1740 Hz, designed to ensure the laser ablation pattern is not negatively affected by the patient’s eye movement. This is 3 times faster than the speed of the laser’s repetition and helps achieves better post-operative outcomes. Furthermore, it contains a laser that operates at 500 Hz, which is the fastest ablation time for all excimer lasers currently available in the United States, operating at approximately 1.2 seconds per diopter.

Additionally, in the efficiency analysis, the press release indicates that the platform of the device allows surgeons to customize the user interface touch screen, allowing them to access patient data quickly. Furthermore, the Teneo software is able to treat the manifest refraction and does not require nomogram, streamlining surgical planning and condensing steps prior to treatment, according to the press release. With the system, 3 steps are required: select patient, choose and confirm treatment, and treat.

The design is also small, which allows more free space for surgeons. According to the press release, Teneo is the smallest excimer laser unit available in the United States. The usability of the device is also designed for comfort for the patient and surgeon. It offers a 350-degree swiveling microscope that can adapt to the surgeon’s height and posture, according to the press release. Further, the bed accommodates patients of all sizes and can be customized for patients to achieve the optimal head position for the surgery. The bed can be swiveled to help position a second treatment device, thus simplifying the surgical process, according to the press release.

“FDA approval of Teneo represents a major milestone for the advancement of laser vision correction technology in the United States,” George Waring IV, MD, ophthalmologist and founder and medical director of the Waring Vision Institute at Mt. Pleasant, South Carolina, said in the press release. “In addition to the technological advantages Teneo offers, the open air feeling around the laser and quiet performance contribute to a comfortable experience for the patient.”

The device is indicated for the reduction or elimination of myopic astigmatism up to -10.00 D MRSE, with sphere between -1.00 D and cylinder between 0.00 and -3.00 D in individuals who are aged 22 years and older and have had stable refraction within the last 12 months, confirmed by clinical records. Additionally, the spherical and cylindrical portions of the manifest distance refraction should not have progressed at more than 0.50 D per year prior to the baseline examination in order for the patient to qualify, according to the press release.

References

Bausch + Lomb receives FDA approval for Teneo excimer laser platform for myopia and myopic astigmatism LASIK vision correction surgery. News release. Bausch + Lomb. January 8, 2024. Accessed January 9, 2024. https://www.bausch.com/news/?id=195