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# Warning Letter to Ocular Therapeutix Over Post-Approval Study
- URL: https://www.fdaweb.com/warning-letter-to-ocular-therapeutix-over-post-approval-study/
- Published: 2018-10-19T12:00:00.000Z
- Updated: 2026-09-15T00:39:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142631

FDA has issued Ocular Therapeutix a 10/17 Warning Letter over the company’s compliance with data collection and information reporting obligations in a post-approval device exposure registry study required as a condition for PMA approval for ReSure Sealant. The company says it is required to provide periodic reports to the agency on the progress of the study until it is completed. “The company has had discussions with the FDA regarding the conduct of the study and intends to respond to the warning letter from the FDA within the required 15 day period,” it says. ReSure Sealant is a hydrogel ophthalmic wound sealant, indicated for intraoperative management of clear corneal incisions (up to 3.5mm) with a demonstrated wound leak for which a temporary dry surface can be achieved, in order to prevent postoperative fluid egress from such incisions following cataract surgery with intraocular lens placement in adults.