# K223074: CorNeat EverPatch

- Pathway: 510(k) (Traditional)
- Applicant: Corneat Vision, Ltd.
- Decided: Jun 2, 2023 after 245 days
- Product code: QWU (Prosthesis, Eyelid Spacer/Graft, Polymer)
- Device class: 2
- Regulation: 21 CFR 886.3130
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921895 (1992). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090078: Kerasys Bioengineered Lamellar Patch Graft, Iop, Inc. (2009) Summary page 4.

## Recalls of this device
- Aug 18, 2025 · Class II · Z-0039-2026: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
- Aug 18, 2025 · Class II · Z-0040-2026: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
- Oct 16, 2024 · Class II · Z-2537-2025: Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.

## Indications for use
The CorNeat EverPatch is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.

Source page: https://510kreport.com/device/K223074
Methodology: https://510kreport.com/methodology