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.