HIGH

CorNeat Vision Recalls Surgical Matrix Over Labeling Issue

CorNeat Vision recalled the CorNeat EverPatch surgical matrix on October 16, 2024. The recall affects the product's labeling for prevention and management of wound dehiscence. Distribution spans across the U.S. and several countries.

Quick Facts at a Glance

Recall Date
October 16, 2024
Hazard Level
HIGH
Brand
CORNEAT VISION
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CORNEAT VISION, LTD. or your healthcare provider for instructions. Notification method: E-Mail

Product Details

The recalled product is the CorNeat EverPatch with REF: 1036295. It measures 5.0 mm x 6.5 mm x 100 um and is classified as RX only. It has been distributed worldwide, including states such as CA, FL, NY, and internationally in Argentina and Israel.

The Hazard

The recall was initiated due to complaints regarding the effectiveness of the product. The labeling correction is necessary to include information on preventing and managing wound dehiscence.

Reported Incidents

There are no specific reported incidents or injuries related to this recall. The recall is precautionary in nature.

What to Do

Patients and healthcare providers should stop using the CorNeat EverPatch immediately. Follow the recall instructions provided and contact CORNEAT VISION, LTD. or your healthcare provider for further guidance.

Contact Information

For more information, contact CORNEAT VISION, LTD. via email or visit their website. Additional details are available at the FDA recall page.

Key Facts

  • Recall Date: October 16, 2024
  • Class II medical device
  • Product distributed worldwide
  • Affected states include CA, NY, TX
  • Contact CORNEAT VISION for instructions

Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI-DI: G16010362950
Affected States
ALL
Report Date
September 17, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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