Foldable Monofocal Toric 1-Piece Intraocular Lens - India CDSCO Medical Device Registration

Foldable Monofocal Toric 1-Piece Intraocular Lens is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000282_ceef6f61ddda912dc66f37ff1847d221_fb25c18815754b7a7031a059bd5e810f. This device is marketed under the brand name TECNIS Toric II 1-Piece Intraocular Lens. 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 Monofocal Toric 1-Piece Intraocular Lens

UID: IMP/MD/2018/000282_ceef6f61ddda912dc66f37ff1847d221_fb25c18815754b7a7031a059bd5e810f

Brand Name

TECNIS Toric II 1-Piece Intraocular Lens

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 Toric (TECNIS Toric II 1-Piece Intraocular Lens) 1-Piece posterior chamber intraocular lenses are intended for primary implantation for 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, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision. This device is intended to be placed in the capsular bag.

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Foldable Monofocal Toric 1-Piece Intraocular Lens

Brand: TECNIS Synergy Toric II OptiBlue IOL with TECNIS simplicity delivery system

Johnson & Johnson Surgical Vision India Private Limited

Class C

Foldable Monofocal Toric 1-Piece Intraocular Lens

Brand: TECNIS Synergy Toric II OptiBlue IOL with TECNIS simplicity delivery system

Johnson & Johnson Surgical Vision India Private Limited

Class C

Foldable Monofocal Toric 1-Piece Intraocular Lens

Brand: TECNIS Synergy Optiblue IOL

Johnson & Johnson Surgical Vision India Private Limited

Class C

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