HIGH

CorNeat Vision Recalls Surgical Matrix Over High Dehiscence Risk

CorNeat Vision recalled 630 units of the EverPatch surgical matrix on August 18, 2025. The recall follows complaints of conjunctival wound dehiscence leading to potential exposure of the surgical patch. The product was distributed worldwide, including across numerous U.S. states.

Quick Facts at a Glance

Recall Date
August 18, 2025
Hazard Level
HIGH
Brand
CorNeat Vision
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

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

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Product Details

The recalled product is CorNeat EverPatch, REF: 1036295. The dimensions are 5.0 mm x 605 mm x 100 µm. It was distributed in the U.S. and other countries.

The Hazard

The recall stems from reports indicating that conjunctival wound dehiscence may occur, which could lead to early exposure of the surgical patch. This presents a significant risk to patients undergoing surgery.

Reported Incidents

The recall does not specify exact numbers of reported incidents related to injuries. No deaths have been reported.

What to Do

Patients and healthcare providers should stop using this device immediately. Contact CorNeat Vision, Ltd. or your healthcare provider for further instructions.

Contact Information

For more information, email CorNeat Vision, Ltd. at the address provided in the recall notification.

Key Facts

  • Recall date: August 18, 2025
  • Quantity recalled: 630 units
  • Distribution: U.S. states and worldwide
  • Manufacturer: CorNeat Vision, Ltd.

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
All Lots/ UDI: G16010362950
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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