FDA Approves TECNIS Toric II 1-Piece Intraocular Lens for Cataract Patients with Astigmatism

 FDA Approves TECNIS Toric II 1-Piece Intraocular Lens for Cataract Patients with Astigmatism

Johnson & Johnson Vision announced the Food and Drug Administration (FDA) approval and U.S. launch of TECNIS Toric II 1-Piece Intraocular Lens (IOL). This is the first product approved on the new TECNIS Toric II platform, which offers more surface texture and friction on the IOL haptics, which holds an IOL in proper position within the eye.

The company is launching two post-market clinical trials to demonstrate the rotational stability and visual outcomes offered by the TECNIS Toric II platform. The trials will be conducted at up to 50 sites across the U.S. to collect qualitative and quantitative measures with up to 1,000 patients. 

Astigmatism is highly prevalent, affecting nearly half of the 24.4 million cataract patients in the U.S., yet it often goes untreated during cataract surgery. Toric IOLs are the most predictable method for correction, however, surgeon concerns around rotational stability may be acting as a barrier to providing treatment. Properly implanting a toric IOL can be more challenging than a conventional spherical IOL due to the high degree of precision required to align the lens properly in order to correct the astigmatism present in the eye. Movement of the lens after implantation can result in decreased vision and the need for realignment.

“With the launch of TECNIS Toric II IOL, our goal is to provide surgeons with a higher degree of confidence in treating astigmatism so that more cataract patients can enjoy clear, high quality vision,” said Xiao-Yu Song, Global Head of Research & Development, Johnson & Johnson Vision. “This advance represents the latest addition to our TECNIS Family of IOLs, building on our proud history of raising the standard of care for patients with cataracts.”

INDICATIONS: The TECNIS Toric II 1-Piece and TECNIS Toric 1-Piece IOL posterior chamber lenses are indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

Full press release: https://www.jjvision.com/press-release/johnson-johnson-vision-introduces-tecnis-toric-ii-1-piece-iol-new-monofocal-option

Source: Johnson & Johnson Vision

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