CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
Summary
The FDA issued a Class II for CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5 by CORNEAT VISION, LTD.. Reason: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch..
Details
Source
Device Recall
External ID
Z-0039-2026
Action Date
2025-10-15
Status
Ongoing
Category
device
Product Description
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
Lot/Code Info: All Lots/ UDI: G16010362950
Quantity Affected: 630 units
Reason for Recall
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-18
Company
Ra'Anana
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CORNEAT VISION, LTD. has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CORNEAT VISION, LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CORNEAT VISION, LTD. have FDA actions?
CORNEAT VISION, LTD. has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0039-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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