Class II

Medical Device Recall: CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only

CORNEAT VISION, LTD. · October 16, 2024

Reason for Recall

Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

N/A

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2537-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.