CDSCO UID IMP/MD/2018/000389_ac61635f4717f6e7d769f2556c97825a_c561eaf1544a3b5d4f4614979b6678d6
Foldable Extended Range of Vision Trifocal Toric 1-Piece Intraocular Lens
Johnson & Johnson Surgical Vision India Private Limited·Device Class Class C·India CDSCO·Brand: TECNIS Synergy Toric II OptiBlue IOL with TECNIS simplicity delivery system
Registration details
- UID
- IMP/MD/2018/000389_ac61635f4717f6e7d769f2556c97825a_c561eaf1544a3b5d4f4614979b6678d6
- 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 lens models ZFW100, ZFW150, ZFW225, ZFW300, ZFW375, ZFW450, ZFW525, ZFW600 are indicated for the primary implantation for the visual correction of aphakia and pre-existing corneal astigmatism in [1] astigmatic adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and [2] aphakia following refractive lensectomy in astigmatic presbyopic adults, who desire improved uncorrected vision, reduction of residual refractive cylinder, useful near vision and reduced spectacle dependence across a range of distances. The intraocular lenses are intended to maintain rotational stability after implantation in the capsular bag
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About this record
Foldable Extended Range of Vision Trifocal Toric 1-Piece Intraocular Lens is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000389_ac61635f4717f6e7d769f2556c97825a_c561eaf1544a3b5d4f4614979b6678d6. 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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