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

Foldable Extended Range of Vision 1-Piece IOL 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_68230f07f1d82792e3152c656a19fcfa_31fa4647608a20dc526790f030bb2069. This device is marketed under the brand name TECNIS Eyhance IOL with TECNIS Simplicity™ Delivery System. The license holder is Johnson & Johnson Surgical Vision India Pvt Ltd ,Shed No. 3, Block No.2, South Facing, Ground Floor, Survey No. 389, 400/2A Part, Padur Main Road, Kuthambakkam 600124, Poonamallee Taluk, Triuvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, 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 1-Piece IOL with Tecnis Simplicity Preloaded Delivery System

UID: IMP/MD/2018/000389_68230f07f1d82792e3152c656a19fcfa_31fa4647608a20dc526790f030bb2069

Brand Name

TECNIS Eyhance IOL with TECNIS Simplicity™ Delivery System

License Holder

Johnson & Johnson Surgical Vision India Pvt Ltd ,Shed No. 3, Block No.2, South Facing, Ground Floor, Survey No. 389, 400/2A Part, Padur Main Road, Kuthambakkam 600124, Poonamallee Taluk, Triuvallur District ,Tiruvallur Tamil Nadu ,600124 ,India

Device Class

Class C

Approving Authority

CDSCO

Product Information

The TECNIS Simplicity™ Delivery System, model DXR00 is used to fold and assist in inserting the TECNIS Symfony® IOL which is indicated for primary implantation for the visual correction of aphakia 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 distance including far, intermediate and near, and increased spectacle independence. This device is intended to be placed in the capsular bag.

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