Z-0039-2026Class II

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

Name: Z-0039-2026 CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m
Creator: Corneat Vision, Ltd.
Published: 2025-08-18
License: https://open.fda.gov/license/

Corneat Vision, Ltd. / initiated 2025-08-18 / Open, Classified

FDA source

CORNEAT VISION, LTD. began a recall of CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m on 2025-08-18. FDA classified it as Class II and gives the reason as "Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0039-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-18
Posted: 2025-10-03
Recalling firm: Corneat Vision, Ltd.
Product: CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m
Product code: QWU Prosthesis, Eyelid Spacer/Graft, Polymer
Reason for recall: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
FDA root cause: Unknown/Undetermined by firm
Action: On August 18, 2025, CorNeat Vision, Ltd. issued a "Urgent: Medical Device Recall" Notification to affected consignees via E-Mail. CorNeat ask consignees to take the following actions: 1. Review inventory, Quarantine and Discontinue use of All Lots of the CorNeat EverPatch and/or EverPatch+. 2. Please discard any unused product. 3. Eyecare providers should continue to monitor patients who have had CorNeat EverPatch and/or EverPatch+ implanted at the follow-up frequency necessary to detect signs of wound dehiscence or conjunctival thinning/erosion. 4. Patients should be instructed to seek prompt follow-up if they experience any signs or symptoms consistent with this complication. 5. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 6. Please fill in the MEDICAL DEVICE RECALL RETURN RESPONSE form at www.corneat.com/everpatch-recall or fill in the attached form and forward to CorNeat Vision by email to [email protected] .
Quantity in commerce: 630 units
Distribution: 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.
Product codes and lots: All Lots/ UDI: G16010362950

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0039-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0039-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-03
Z-0040-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-03

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)