The multifocal toric IOL lens is designed to treat cataracts and correct presbyopia. The proposed indication for the combination IOL, as stated in Alcon’s submission.
On Friday, the U.S. Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory Committee voted unanimously in favor of the premarket approval application for the AcrySof IQ ReSTOR +3.0 D multifocal toric intraocular cataract lens (IOL), submitted by Alcon. The materials for this meeting can be found HERE.
The multifocal toric IOL lens is designed to treat cataracts and correct presbyopia. The proposed indication for the combination IOL, as stated in Alcon’s submission, is for “primary implantation for the visual correction of aphakia and preexisting astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia who desire near, intermediate and distance vision, reduction of residual refractive cylinder and increased spectacle independence.”
The two voting questions asked of the committee during this meeting had to do with whether the panelists feld there was 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 for use in patients who meet those criteria.
The panel voted 11-1 that the benefits of the IOL outweigh the risks for use in patients who meet the criteria specified in the proposed indication.
“Despite a little bit of controversy about the patient subjective outcomes, I think the objective data was compelling,” noted Bennie H. Jeng, MD, MS of the FDA’s Ophthalmic Devices Panel.
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