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FDA panel recommends premarket approval application for AcrySof IQ ReSTOR multifocal toric IOL
GAITHERSBURG, Md. — In an overwhelming panel vote, the U.S. Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory Committee voted to recommend Alcon’s premarket approval application for the AcrySof IQ ReSTOR +3.0 D multifocal toric IOL.The 12-member panel voted a unanimous “yes” on two questions: whether there is reasonable assurance that the AcrySof IQ ReSTOR multifocal toric posterior chamber IOL is safe for use in patients who meet the criteria specified in the proposed indication and whether there is reasonable assurance that the lens is effective (Read more...)