FDA inspectors found Oculus Surgical’s procedures for receiving, reviewing and evaluating complaints to be lacking following a December 2017 inspection of the firm’s Stuart, Florida manufacturing facility.
The firm released defective devices to customers, and although defects were identified by sales representatives at the customer site, they were not documented as complaints, the agency found.
An investigation was not launched because a previous investigation was performed for similar complaints. However, there was no documentation of the investigations or a corrective and preventive action plan.
The FDA said Oculus had not determined the probable cause of the recurrence of these types of complaints.