FDA 483 - Alcon Research, LTD. - February 23, 2018

Alcon Research, LTD. in Sinking Spring, PA, a device manufacturer, was cited for inadequate procedures for receiving, reviewing, and evaluating complaints. The inspection revealed issues with missing lot code information, inconsistent application of 'As Reported Terms' and 'Event Codes', and non-uniform utilization of fields for complaint data analysis, particularly concerning the CyPass 241 device. These deficiencies indicate significant problems in their complaint handling system.