Foldable 1-Piece Acrylic Posterior Chamber Intraocular Lens with Tecnis Simplicity Preloaded Delivery System - India CDSCO Medical Device Registration

Foldable 1-Piece Acrylic Posterior Chamber 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_ad0306189f97d2e8994ff82c6a616cfc_bb734cecd7fb69e9d6ed1a83f89ae732. 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 1-Piece Acrylic Posterior Chamber Intraocular Lens with Tecnis Simplicity Preloaded Delivery System

UID: IMP/MD/2018/000389_ad0306189f97d2e8994ff82c6a616cfc_bb734cecd7fb69e9d6ed1a83f89ae732

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 is used to fold and assist in inserting the TECNIS Eyhance IOL which is indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens extends the depth of focus, which improves vision for intermediate tasks, and provide similar distance vision as compared to a standard aspheric monofocal IOL. The lens is indicated for placement in the capsular bag only

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