The requirement is for FDA approved consumable intraocular lenses (IOLs) for use in cataract surgery at Naval Medical Center, Camp Lejeune (NMCCL). Specifically, TECNIS Simplicity TECNIS Eyhance, TECNIS Eyhance Toric II 1-Piece IOL, TECNIS Symfony IOL OptiBlue IOL Simplicity Lenses, and TECNIS Symfony OptiBlue Toric II IOL Simplicity are required. The power range required for the IOLs is +5.0 to +34.0. The required monofocal lenses, TECNIS Simplicity TECNIS Eyhance and TECNIS Eyhance Toric II 1-Piece IOL, shall elongate a single focal point into a dynamic full range of vision from distant to near points. Improved intermediate vision over standard monofocal lenses is required. The depth to focus extended vision lenses (TECNIS Symfony IOL OptiBlue IOL Simplicity and TECNIS Symfony OptiBlue Toric II IOL Simplicity) shall correct chromatic aberration and enhance image contrast. The depth to focus extended vision lenses shall deliver visual acuity over a continuous range of distances while maintaining high contrast. The government requires that IOLs not used by NMCCL be returned at no cost IAW the Ship 2 return 1 program offered by Johnson & Johnson (J&J) Vision.

Only J&J Vision was found to offer the lens types required. This is a Brand Name Only requirement. Only J&J Vision manufactures the depth to focus extended vision lenses (TECNIS Symfony IOL OptiBlue IOL Simplicity and TECNIS Symfony OptiBlue Toric II IOL Simplicity) that meet the required patient outcome based on research. The TECNIS Symfony has a proprietary relief profile, which elongates focus. The proprietary achromatic lens technology of the TECNIS Symfony corrects chromatic aberration and enhances image contrast. The unique diffractive pattern and achromatic technology deliver visual acuity over a continuous range of distances while maintaining high contrast performance. J&J Vision manufactures the only available monofocal lenses (TECNIS Simplicity TECNIS Eyhance and TECNIS Eyhance Toric II 1-Piece IOL) that elongate a single focal point into a dynamic full range of vision from distant to near points. The TECNIS Eyhance lens is the only monofocal IOL with a spherical posterior surface and a modified aspheric anterior surface, which extends the depth of focus. This provides improved intermediate vision compared to all other aspheric shaped monofocal IOLs.

See Attached J&A.