Medical Devices

ReSure® Sealant - P130004

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Picture of the device.

Product Name: ReSure® Sealant
PMA Applicant:
Ocular Therapeutix, Inc.
Address:
36 Crosby Drive, Suite 101, Bedford, MA 01730
Approval Date:
January 8, 2014
Approval Letter:
http://www.accessdata.fda.gov/ cdrh_docs/pdf13/P130004a.pdf

What is it?  ReSure Sealant prevents leakage from a cut (incision) in the cornea. It is made of two solutions, a polyethylene glycol solution and a trilysine amine solution. It is applied to a corneal incision using an applicator.

How does it work? When the two solutions are mixed together, they combine to form the sealant gel. The applicator is used to apply the liquid sealant on the corneal incision. The applied liquid turns into a gel within approximately 20 seconds. In most cases the sealant remains on the eye for less than 3 days. During this period, the gel softens, detaches, and is removed in the tears.

When is it used? ReSure Sealant is used during surgery to seal leaking incisions in the cornea following cataract surgery (surgery to remove the natural lens that has become cloudy and difficult to see through) with intraocular lens (IOL) implantation in adults.

What will it accomplish? ReSure Sealant is meant to help prevent leakage from corneal incisions following cataract surgery with IOL placement. In a clinical study, out of 295 corneal incisions in which the sealant was applied, 12 leaks occurred within 1 week of the surgery (4.1%).

When should it not be used? When used as recommended, there are no known conditions when this product should not be used.

recommended, there are no known conditions when this product should not be used.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

Other Resources:

 

Page Last Updated: 04/01/2014
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