The Recall Desk
HighFDA (Devices)·Z-0039-2026·Announced 2025-10-15

Ocular surgical matrix recalled after complaints of early patch exposure

CorNeat Vision is recalling 630 CorNeat EverPatch units after reviewed complaints identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: complaints identify early exposure of an implanted ocular patch, a clinical risk with no injury count stated.

Plain-English summary

The CorNeat EverPatch, REF 1036295, a permanent tissue-integrating surgical matrix measuring 5.0 mm x 605 mm x 100 micrometres, is being recalled.

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

The recall covers 630 units across all lots, UDI G16010362950, distributed worldwide including in Arizona, California, Colorado, Connecticut, the District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas and Massachusetts among other states. The FDA has classified the action as Class II.

Surgeons and facilities holding the product should follow CorNeat Vision's instructions.

The recalled product

Product
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
Manufacturer
CORNEAT VISION, LTD.
Category
Medical Device — Ophthalmic implant
Hazard
  • wound-dehiscence
  • device-exposure
  • implant

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots/ UDI: G16010362950

Distribution

Distributed nationwide across the United States.

Related recalls

Same category