AcrySof® IQ IOL with ULTRASERT Delivery System 에 대한 현장 안전성 서한

Field Safety Notice

2016-07-29

Slovenia

AMPMDRS

Alcon is initiating a medical device removal for specific lots of the acrysof® iq intraocular lens (iol) with ultraserttm delivery system. we are initiating this voluntary removal because we have determined the ultraserttm delivery systems from certain lots have an interior surface characteristic that could result in the iol becoming lodged in the ultraserttm delivery system. most likely if this happens the lens would not be delivered and the surgery could be completed with a standby lens; however, if the lens is forced through the nozzle this could result in damage to the lens and/or nozzle, possibly injuring the patient. please note that this event affects only a small portion of the ultraserttm delivery systems within the specified production lots. national competent authorities have been notified of this action. below please find the full details on this matter and directions for handling potentially-affected product in your practice. details on affected device: the acrysof® iq iol with ultraserttm delivery system is a ce marked medical device. the alcon acrysof® iq iol is an acrylic foldable single-piece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. the acrysof® iq iols are provided in the ultraserttm pre- loaded delivery system for a convenient, controlled means to reliably place these lenses into the capsular bag. .