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Foldable Continuous Range of Vision Toric 1-Piece Intraocular Lens with Tecnis Simplicity Preloaded Delivery System - India CDSCO Medical Device Registration

Foldable Continuous Range of Vision Toric 1-Piece Intraocular Lens with Tecnis Simplicity Preloaded Delivery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000389_eb15d898352f9fa890cb9e60286d9b7b_f3865c4e5897682a64fe5218e40afab6. This device is marketed under the brand name TECNIS Synergy Toric II OptiBlue IOL with TECNIS simplicity delivery system. The license holder is Johnson & Johnson Surgical Vision India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Foldable Continuous Range of Vision Toric 1-Piece Intraocular Lens with Tecnis Simplicity Preloaded Delivery System
UID: IMP/MD/2018/000389_eb15d898352f9fa890cb9e60286d9b7b_f3865c4e5897682a64fe5218e40afab6

Brand Name

TECNIS Synergy Toric II OptiBlue IOL with TECNIS simplicity delivery system

Device Class

Class C

Approving Authority

CDSCO

Product Information

The TECNIS Simplicityโ„ข Delivery System is used to fold and assist in inserting the TECNIS Synergyโ„ข Toric II OptiBlueโ„ข IOL which is indicated for the primary implantation for the visual correction of aphakia and pre-existing corneal astigmatism in [1] astigmatic adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and [2] aphakia following refractive lensectomy in astigmatic presbyopic adults, who desire improved uncorrected vision, reduction of residual refractive cylinder, useful near vision and reduced spectacle dependence across a range of distances. The intraocular lenses are intended to maintain rotational stability after implantation in the capsular bag

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