FDA 483 - Avedro, Inc. - June 26, 2025

An FDA inspection conducted at Avedro, a Glaukos Company, from June 17 to June 26, 2025, identified significant compliance deficiencies, resulting in a Form FDA-483. The inspection highlighted two primary issues. First, the company failed to properly label its KXL System, a Class 1 Laser product, by not affixing new certification labels in conformance with current Laser Notice 56 Guidance. This indicates a deviation from established product certification standards. Second, Avedro had not submitted required annual reports to the FDA for the KXL System since August 2013. These reports are crucial for summarizing maintained records and providing data on product production, sales, or installation volumes. This long-standing failure persisted despite changes in the firm's address and name. These observations indicate non-compliance with federal regulations governing medical devices and laser products, enforced under the Federal Food, Drug, and Cosmetic Act. Avedro acknowledged these observations and indicated a commitment to correcting both identified issues. The company is required to implement corrective actions to address the labeling non-conformity and ensure timely submission of all future annual reports to meet regulatory obligations.