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Refractive Extended Depth of Focus Intraocular Lens with Simplicity Preloaded Delivery System - India CDSCO Medical Device Registration

Refractive Extended Depth of Focus Intraocular Lens with Simplicity Preloaded Delivery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001148_c040b8e276471b6ad750f3f11f799984_c559b52bd84f08aa76cb24c09f7e4de0. This device is marketed under the brand name TECNIS PureSeeโ„ข IOL with TECNIS Simplicityโ„ข 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
Refractive Extended Depth of Focus Intraocular Lens with Simplicity Preloaded Delivery System
UID: IMP/MD/2023/001148_c040b8e276471b6ad750f3f11f799984_c559b52bd84f08aa76cb24c09f7e4de0

Brand Name

TECNIS PureSeeโ„ข IOL with TECNIS Simplicityโ„ข Delivery System

Device Class

Class C

Approving Authority

CDSCO

Product Information

Correction of aphakia following removal of the natural crystalline lens.The TECNIS Simplicityโ„ข Delivery System is used to fold and assist in inserting the TECNIS PureSeeโ„ข IOL which is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. The IOL is intended to be placed in the capsular bag only.

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