ReSure Sealant

Superior Wound Closure

Superior Wound Closure

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Important Safety Information

Warnings:

  • Should not be used on actively leaking incisions in which a temporary dry ocular surface cannot be achieved.
  • Do not use the ReSure Sealant in patients who are allergic to FD&C Blue #1.

Precautions:

  • The ReSure Sealant is provided sterile. Do not use if packaging or seal has been damaged or opened. Do not re-sterilize.
  • The mixing tray, diluent dropper and Applicators should only be used in conjunction with one another.
  • The mixing tray, diluent dropper and Applicators are intended for single-use only. Discard opened and unused product.
  • Prior to application of the ReSure Sealant, ensure incision site is not actively leaking. 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 the ReSure Sealant on corneal incisions without intraoperative leakage was not evaluated in the clinical study.
  • The ReSure Sealant will not replace the need for sutures in certain circumstances, including the need for long term mechanical support to the incision.

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IMPORTANT SAFETY INFORMATION

Indication Statement

INDICATION

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.

WARNINGS

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.

PRECAUTIONS

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.