FDA 483 - Eye-Novation, LLC - June 17, 2024

Eye-Novation, LLC, a medical device manufacturer in Bellevue, WA, was inspected by the FDA from June 3-17, 2024. The inspection revealed widespread deficiencies in the firm's quality system, particularly concerning the TonoWash tonometer tip washer-disinfector. The firm lacked established procedures and documentation for critical areas such as design control, UDI labeling, product identification, quality audits, purchasing controls, finished device acceptance, nonconforming product, complaint handling, MDRs, device history records, document control, and management review.