Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank

CLOSEOUT LETTER Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank MARCS-CMS 680039 — February 09, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Biologics Recipient: Recipient Name Timothy M. Fischer Recipient Title President/Chief Executive Officer Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank 4745 Haven Point Blvd. Carmel , IN 46280 United States Tfischer@visionfirst.org Issuing Office: Division of Biological Products Operations II United States Secondary Issuing Offices United States Dear Mr. Fischer: The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter OBPO 24-680039 dated June 10, 2024. 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 Act(s) 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/ Melissa J. Mendoza Director Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research Content current as of: 02/12/2026 Regulated Product(s) Biologics