Alcon Research, Ltd.: Medical Device Recall in 2016 - (Recall #: Z-1394-2016)

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.

Class II

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.

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

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

Voluntary: Firm initiated