Events

Recall of Device Recall VERION Image Guided System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Research, Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73430
  • Event Risk Class
    Class 2
  • Event Number
    Z-1394-2016
  • Event Initiated Date
    2016-03-01
  • Event Date Posted
    2016-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144201
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, communications, images, ophthalmic - Product Code NFG
  • Reason
    Alcon is conducting a voluntary medical device correction of all verion reference units (vision planner) that are shared with the alcon lensx laser system after receiving reports concerning the inclusion of unplanned arcuates on printed, saved (.Pdf) or exported surgical plans.
  • Action
    Alcon sent an Urgent Medical Device Correction letter dated February 29, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that an Alcon Technical Services Engineers will contact customers, schedule Service Calls, and perform onsite corrections. For questions call 1-800-862-5266.

Device

Device Recall VERION Image Guided System
  • Model / Serial
    Serial Numbers: 1017, 1119, 1123, 1125, 1126, 1128, 1133, 1135, 1136, 1137, 1138, 1139, 1142, 1147, 1150, 1153, 1155, 1161, 1165, 1168, 1172, 1178, 1181, 1182, 1183, 1188, 1190, 1191, 1193, 1196, 1197, 1198, 1199, 1201, 1203, 1206, 1207, 1220, 1226, 1228, 1230, 1232, 1250, 1256, 1258, 1259, 1421, 1433, 1435, 1439, 1451, 1452, 1506, 1508, 1509, 1523, 1536, 1548, 1559, 1562, 1565, 1568, 1581, 1597, 1606, 1628, 1632, 1649, 1661, 1663, 1668, 1671, 1694, 1696, 1705, 1716, 1726, 1729, 1798, 1816, 1818, 1820, 1824, 1829, 1921, 1922, 1934, 1937, 1938, 1940, 1942, 1954, 1957, 2057, 2069, 2086, 2092
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide throughout the US and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Czech Republic, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Greece, Guatlemala, Hungary, India, Indoesia, Isreal, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Norway, Panama, Philippines, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, UK, Ukrain, United Arab Emirates
  • Product Description
    VERION Reference Unit (Vision Planner) || Product Usage: || The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the patients eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.
  • Manufacturer
    Alcon Research, Ltd.

Manufacturer

Alcon Research, Ltd.
  • Manufacturer Address
    Alcon Research, Ltd., 6201 South Fwy, Fort Worth TX 76134-2099
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    USFDA