CORNEAT VISION, LTD.: Device Recall

Recall #Z-0039-2026 · 08/18/2025

Class II: Risk

Recall Details

Recall Number: Z-0039-2026
Classification: Class II
Product Type: Device
Recalling Firm: CORNEAT VISION, LTD.
Status: Ongoing
Date Initiated: 08/18/2025
Location: Ra'Anana, Israel
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 630 units

Reason for Recall

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

Product Description

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

Distribution Pattern

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.

Other Recalls by CORNEAT VISION, LTD.

Class II: Risk 08/18/2025

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Class II: Risk 10/16/2024

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

View all recalls by CORNEAT VISION, LTD. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.