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

Foldable Extended 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_a66d79bd6690f50cb5a92ade4f7c6f20_056ebc4fa0251f0874ad593e37398dac. 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 Extended Range of Vision Toric 1-Piece Intraocular Lens with Tecnis Simplicity Preloaded Delivery System
UID: IMP/MD/2018/000389_a66d79bd6690f50cb5a92ade4f7c6f20_056ebc4fa0251f0874ad593e37398dac

Brand Name

TECNIS Synergy Toric II OptiBlue IOL with TECNIS simplicity delivery system

Device Class

Class C

Approving Authority

CDSCO

Product Information

The TECNIS Simplicity Delivery System is used to fold and assist in inserting the TECNIS Symfony Toric II OptiBlue Extended Range of Vision IOLs which are indicated for primary implantation for the visual correction of aphakia and pre-existing corneal astigmatism in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, a reduction of residual refractive cylinder, and increased spectacle independence. The lenses are intended to be placed in the capsular bag only

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