Z-2537-2025Class II

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um...

Name: Z-2537-2025 CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um...
Creator: Corneat Vision, Ltd.
Published: 2024-10-16
License: https://open.fda.gov/license/

Corneat Vision, Ltd. / initiated 2024-10-16 / Open, Classified / root cause: labeling and UDI

FDA source

CORNEAT VISION, LTD. began a recall of CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only on 2024-10-16. FDA classified it as Class II and gives the reason as "Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2537-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-16
Posted: 2025-09-05
Recalling firm: Corneat Vision, Ltd.
Product: CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Product code: QWU Prosthesis, Eyelid Spacer/Graft, Polymer
Reason for recall: Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: On October 16-17, 2024, Corneat Vision provided customers with an email containing important information concerning the device safety and efficacy related CorNeat EverPatch. Customers were informed that the IFUs were modified to include conditions that may impair healing and reduce he effectiveness of the EverPatch. Surgical practices were advised to maximize success rate.
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.
Product codes and lots: UDI-DI: G16010362950

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2537-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2537-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-05

Product code QWU

K223074Class IICorNeat EverPatchCorneat Vision , Ltd. / cleared 2023-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)