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Foldable 1-Piece, Sterile UV and Violet Light-Filtering Acrylic Preloaded IOL for the UNFOLDER Vitan™ Inserter - India CDSCO Medical Device Registration

Foldable 1-Piece, Sterile UV and Violet Light-Filtering Acrylic Preloaded IOL for the UNFOLDER Vitan™ Inserter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000132_eb38ce29aece8460095ff6ad0ea63671_827831c794851fd538a0b889c3788d4a. This device is marketed under the brand name TECNIS Multifocal 1-Piece IOL with TECNIS Simplicity™ Delivery System. The license holder is Johnson & Johnson Surgical Vision India Pvt Ltd, 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, Sterile UV and Violet Light-Filtering Acrylic Preloaded IOL for the UNFOLDER Vitan™ Inserter
UID: IMP/MD/2023/000132_eb38ce29aece8460095ff6ad0ea63671_827831c794851fd538a0b889c3788d4a

Brand Name

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

Device Class

Class C

Approving Authority

CDSCO

Product Information

The SmartLOAD Delivery Technology system, is used in combination with the UNFOLDER Vitan Inserter, Model DK9000 to fold and assist in inserting the TECNIS OptiBlue 1-Piece intraocular lenses for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag

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