CORNEAT VISION, LTD. recalls CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

Recall date

August 18, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0039-2026

FDA classification

Class II

Brand / firm

CORNEAT VISION, LTD.

Sold / distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Japan, Israel, Argentina, Hong Kong.

Why it was recalled

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m