Z-1394-2016Class II

VERION Reference Unit (Vision Planner)

Name: Z-1394-2016 VERION Reference Unit (Vision Planner)
Creator: Alcon Research, Ltd.
Published: 2016-03-01
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2016-03-01 / Terminated / root cause: software

FDA source

Alcon Research, Ltd. began a recall of VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed... on 2016-03-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1394-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-01
Posted: 2016-04-14
Terminated: 2017-04-13
Recalling firm: Alcon Laboratories
Product: 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.
Product code: NFG Device, Communications, Images, Ophthalmic
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software change control
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.
Quantity in commerce: 97 units
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1394-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1394-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14

Product code NFG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)