Staar Surgical Co.

CLOSEOUT LETTER Staar Surgical Co. MARCS-CMS 423326 — June 15, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Staar Surgical Co. United States Issuing Office: United States Los Angeles District 19701 Fairchild Road Los Angeles, CA 92612 VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED June 15, 2018 Ms. Caren Mason, President and Chief Executive Officer STAAR Surgical Company 1911 Walker Avenue Monrovia, CA 91016 Dear Ms. Mason: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #20-14), dated 05/21/2014. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Kelly D. Sheppard Compliance Branch Director Division 3/West Office of Medical Device and Radiological Health Operations Content current as of: 06/21/2018 Regulated Product(s) Medical Devices