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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAcrySof ReStor +2.5 D Multifocal Intraocular lens /Toric Intraocular Lens/3.0 D Multifocal Toric Intraocular Lenses/ Tor
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP040020
Supplement NumberS070
Date Received06/06/2017
Decision Date09/21/2017
Product Code MFK 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order 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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