AcrySof ReStor +2.5 D Multifocal Intraocular lens /Toric Intraocular Lens/3.0 D Multifocal Toric Intraocular Lenses/ Tor
FDA premarket approval P040020/S070 · decided 2017-09-21
Approval details
- PMA number
- P040020
- Supplement
- S070
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AcrySof ReStor +2.5 D Multifocal Intraocular lens /Toric Intraocular Lens/3.0 D Multifocal Toric Intraocular Lenses/ Tor
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2017-06-06
- Decision date
- 2017-09-21
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approved for use of the Enhanced Dry NIMO Wavefront Measurement System for quality control inspection of optical performance for in situ spherical equivalent and cylindrical powers, image quality, spherical aberration and labeled axis of AcrySof® Toric Intraocular Lenses (IOLs), and spherical aberration and labeled axis of AcrySof® Multifocal and Multifocal-Toric Intraocular Lenses.
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