Superior Wound Closure
By cbecker
The Food and Drug Administration’s (FDA) Ophthalmic Devices Panel concluded that ReSure Sealant (Ocular Therapeutix, Inc., Bedford, MA), a first-of-a-kind medical device in the United States, is safe and effective for the management of clear corneal wound leaks following cataract surgery. During this meeting, the panel reviewed data from the ReSure Sealant Pivotal Study, a […]
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ReSure is 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, to prevent postoperative fluid egress from such incisions following cataract surgery with intraocular lens (IOL) placement in adults.
ReSure should not be used on actively leaking incisions in which a temporary dry ocular surface cannot be achieved. • Do not use in patients who are allergic to FD&C Blue #1.
ReSure is for single-use only. Prior to use, remove any standing moisture from the surrounding ocular surface and incision and ensure that the site is dry. • Use within 30 minutes of removing the mixing tray from foil pouch. • Prophylactic use of ReSure Sealant on corneal incisions without intraoperative leakage was not evaluated in clinical studies. • ReSure Sealant will not replace the need for sutures in certain circumstances, including the need for long term mechanical support to the incision.
The most commonly reported ocular adverse events during the clinical study included: worsening best corrected visual acuity, BCVA (7%), increase in IOP (5%), eye pain (3%), posterior vitreous detachment (2%), inflammation (1%).
Please see full Instructions for Use.