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TENEO, ™

TENEO, ™

TENEO, ™

Product catalog summary
Introduction
TENEO is the first excimer laser platform to receive FDA approval in 17 years, designed by Bausch + Lomb to enhance surgeon and patient comfort and safety. It offers advanced features without the need for a nomogram, streamlining the surgical workflow.

Specifications
  • Size: 29.3 sq. ft., including the patient bed, making it the smallest excimer laser in the U.S.
  • Eye-tracker: Operates at 1,740Hz, the fastest in the U.S.
  • Laser Speed: Operates at 500Hz, with the fastest ablation time in the U.S. (1.2 seconds per diopter).

Efficiency and Usability
  • GUI Touchscreen: Offers customized views and easy access to patient data.
  • Software: Innovative, requiring no nomogram, with intuitive data entry and automatic cylinder conversion.
  • Energy Checks: Unlimited treatments between energy checks, which occur every two hours.

Patient and Surgeon Experience
  • Microscope: Adjustable for surgeon height and posture.
  • Treatment Bed: Customizable with a swing-out design for easy access and adjustable head positioning.
  • Performance: Quiet operation.

Clinical Outcomes
At nine months postoperative, 97.8% of eyes achieved 20/25 vision or better, and 99.9% achieved 20/40 or better. Over half of the patients reached 20/16 or better, with 34.8% gaining one or more lines of CDVA. Between one and nine months, 90.2% of eyes maintained MRSE within 0.50 D.

Patient Satisfaction
High satisfaction rates were reported, with 99% of patients experiencing little to no difficulty driving at night and 98% overall satisfaction.

Safety and Compliance
The TENEO complies with 21 CFR 1040.10 and 1040.11, with specific deviations. It is a Class 4 laser product with a wavelength of 193 nm and a maximum pulse frequency of 500 Hz.

Indications and Safety Information
The Technolas Teneo 317 Model 2 is indicated for LASIK in patients with specific myopic astigmatism conditions. It is contraindicated in patients with certain diseases and conditions, such as connective tissue diseases, keratoconus, and uncontrolled diabetes. Potential risks include flap complications, visual symptoms, and dry eye syndrome.

Conclusion
TENEO represents a significant advancement in excimer laser technology, offering improved outcomes and patient satisfaction. For more information, visit bauschsurgical.com/refractive/teneo/.
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Catalog excerpts

TENEO, ™ -1

TENEO,™ the first excimer platform to earn FDA approval in 17 years, is more than just a new laser — it's an extension of brilliance. Purposeful and purpose-built, TENEO redefines excimer technology. Bausch + Lomb engineers designed each feature specifically for the comfort and safety of surgeons and their patients. With TENEO's state-of-the-art features, you can deliver outcomes you need to see to believe — all with no nomogram required.

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TENEO, ™ -2

TENEOs intuitive s°ftware enab|es a smooth 2. Choose and confirm treatmentand efficient process from end to end withthree easy steps: (3 3. TreatPrecise Intentional UnparalleledEngineering Efficiency ExperienceSmall footprint • 29.3 sq. ft., including the patient bed • The smallest excimer laser available in the U.S. Advanced eye-tracker • Operates at 1,740Hz (more than 3x the laser's repetition rate) High-speed laser • Operates at 500Hz • The fastest ablation time in the U.S. • Based on calculation using an optical zone of 6mm and a standard myopic treatment (PROSCAN mode) GUI touchscreen •...

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TENEO, ™ -3

Exceptional Outcomes Comparison of Postoperative Cumulative UDVA and Preoperative CDVA1 316 eyes 9 months postop Preop CDVA • Over half of patients achieved 20/16 or better • 97.8% of eyes showed 20/25 or better and 99.9% of eyes showed 20/40 or better At nine months postoperative With TENEO, you’ll experience outcomes you need to see to believe. Look forward to incredible results such as: • 34.8% of eyes gained 1 or more lines of CDVA Cumulative snellen VA (20/x or better) n=316 eyes Mean MRSE by Visit1 (All Treated Eyes) Between one and nine months postoperative within 0.50 D. Mean ± SD of...

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TENEO, ™ -4

Exceptional Outcomes No / little Difficulty Performing Daily Activities2 • 99% of patients reported having little to no difficulty driving at night • LASIK performed with the TENEO Patient Quality of Life / Satisfaction yielded high (98%) patient satisfaction 0% Driving during daytime Driving in difficult conditions Active sports or other outdoor activities Activities requiring near vision Reading ordinary print in newspaper Reading small print in a telephone book, on a medicine bottle or on legal forms Satisfaction with Present Vision2 (somewhat to very satisfied) p <0.001 2. Stonecipher, K,...

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TENEO, ™ -5

Exceptional Outcomes Contrast Sensitivity: Without Glare Preop Contrast Sensitivity Significant post-op improvement in contrast sensitivity With Glare Preop Ready to experience transformed excimer technology? Get in touch at bauschsurgical.com/refractive /teneo/ Bausch + Lomb Surgical, Refractive | 3365 Tree Court Ind. Blvd., St. Louis, MO 63122

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TENEO, ™ -6

Indications and Important Safety Information for Technolas Teneo 317 Model 2 System Indications for Use. The Technolas Teneo 317 Model 2 is indicated for laser-assisted in situ keratomileusis (LASIK) in: (1) Patients for the reduction or elimination of myopic astigmatism up to -10.00 D MRSE, with sphere between -1.00 D to -10.00 D and cylinder between 0.00 and -3.00 D; (2) Patients who are 22 years of age or older; (3) Patients must have a stable refraction in the last 12 months, as documented by previous clinical recordings, i.e., the spherical and cylindrical portions of the manifest distance...

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