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

Foldable Multifocal 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_a032b497a9e7d0c3aadb571736e04c18_d5fb804974cc36eed673432721acb5e1. 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 Multifocal 1-Piece Intraocular Lens with Tecnis Simplicity Preloaded Delivery System

UID: IMP/MD/2018/000389_a032b497a9e7d0c3aadb571736e04c18_d5fb804974cc36eed673432721acb5e1

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® multifocal IOL which is indicated for primary implantation for the visual correction of [1] aphakia in adults with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification, and [2] aphakia following refractive lensectomy in presbyopic adults who desire improved uncorrected near, intermediate, and distance vision and increased spectacle independence across a range of distances. The intraocular lens is intended to be placed in the capsular bag

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Foldable Multifocal 1-Piece Intraocular Lens with Tecnis Simplicity Preloaded Delivery System

Brand: TECNIS Multifocal 1-Piece IOL with TECNIS Simplicity™ Delivery System

Johnson & Johnson Surgical Vision India Pvt Ltd

Class C