Foldable 1-Piece, Sterile UV and Violet Light-Filtering Acrylic Preloaded IOL for the UNFOLDER Vitan™ Inserter
- UID
- IMP/MD/2018/000389_eb38ce29aece8460095ff6ad0ea63671_827831c794851fd538a0b889c3788d4a
- Device class
- Class C
- Brand name
- TECNIS Synergy Toric II OptiBlue IOL with TECNIS simplicity delivery system
- License holder
- Johnson & Johnson Surgical Vision India Private Limited
- 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
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/2018/000389_eb38ce29aece8460095ff6ad0ea63671_827831c794851fd538a0b889c3788d4a. This device is marketed under the brand name TECNIS Synergy Toric II OptiBlue IOL with TECNIS simplicity delivery system. The license holder is Johnson & Johnson Surgical Vision India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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