Bausch + Lomb Receives FDA Approval for TENEO Excimer Laser Platform for Myopia and Myopic Astigmatism LASIK Vision Correction Surgery - Seite 2

“FDA approval of TENEO represents a major milestone for the advancement of laser vision correction technology in the United States,” said George Waring IV, M.D., ophthalmologist and founder and medical director, Waring Vision Institute, Mt. Pleasant, S.C. “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.”

For more information, visit https://www.bauschsurgical.com/refractive/teneo/.

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 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 refraction have not progressed at a rate of more than 0.50 D per year prior to the baseline examination in the eye(s) to be treated.

WARNING. Danger of injury due to failure to observe the patient selection criteria! Failure to observe the contraindications and potential adverse effects may result in serious permanent patient injury. The usage of the laser system is limited to a specific field of applications. Observe the contraindications and potential adverse effects listed in the User Manual before selecting a patient and starting any treatment.

Contraindications. Contraindications of the Technolas Teneo 317 Model 2 include patients: (1) with any type of active connective tissue disease or autoimmune disease; (2) with signs of keratoconus, abnormal corneal topography, and degenerations of the structure of the cornea (including but not limited to pellucid marginal degeneration); (3) with significant dry eyes (severe Dry Eye Syndrome). If patients have severely dry eyes, LASIK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery. It may result in poor vision after LASIK; (4) for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250µ of residual corneal thickness from corneal endothelium; (5) with uncontrolled diabetes; (6) with uncontrolled glaucoma; (7) with active eye infections or active inflammation: (8) with recent herpes eye infection or problems resulting from past infections; (9) with known sensitivity to medications used for standard LASIK surgery.