Events

Field Safety Notices about AcrySof® IQ IOL with ULTRASERT Delivery System

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Alcon Laboratories, Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-07-29
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
    FSCA ID: 2016.069
  • Reason
    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. .

Device

AcrySof® IQ IOL with ULTRASERT Delivery System

Manufacturer

Alcon Laboratories, Inc.
  • Manufacturer Address
    Alcon, farmacevtske storitve, d.o.o. Verovškova ulica 57 1000 Ljubljana Slovenija Tel.: +386 (0)1 422 5280
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    AMPMDRS