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Device | AcrySof IQ ReSTOR Intraocular Lenses |
Generic Name | Lens, multifocal intraocular |
Applicant | Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P040020 |
Supplement Number | S093 |
Date Received | 05/15/2020 |
Decision Date | 07/01/2021 |
Product Codes |
HQL MFK |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for change to the Analytical Testing Method for the determination of Residual Monomer in AcrySof® Intraocular Lenses. |