VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, i

FDA device recall Z-1394-2016 · posted 2016-04-14 · Terminated

Recall details

Recalling firm

Alcon Research, Ltd.

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.

Action taken

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.

Root cause

Software change control

Status

Terminated

Product code

NFG

Quantity affected

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,

Date initiated

2016-03-01

Date posted

2016-04-14

Date terminated

2017-04-13

Location

Fort Worth, TX