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Device | ACRYSOF MULTIFOCAL INTRAOCULAR LENS |
Generic Name | Lens, multifocal intraocular |
Regulation Number | 886.3600 |
Applicant | Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P040020 |
Supplement Number | S060 |
Date Received | 02/04/2016 |
Decision Date | 02/29/2016 |
Product Code |
MFK |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change to a new quality control measurement system for measuring spherical aberrations for the AcrySof® Multifocal IOL Model SN6AD1 at the Cork, Ireland manufacturing site and for the AcrySof® Multifocal IOL Models SN6AD1 & MN6AD1 at the Huntington, West Virginia manufacturing site. |