510(k) Report

FDA applicant

Corneat Vision, Ltd.

Raanana, IL1 decision2023–20233 recalls

FDA records 1 decision for Corneat Vision, Ltd. (Raanana, IL) in 2023: 1 510(k) clearance. All are in product code QWU (Prosthesis, Eyelid Spacer/Graft, Polymer). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Corneat Vision, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

2in 2025

2024: 12025: 2
2023high 2 (2025) · low 0 (2023)2026

Class I Class II/III not classified

FIG. 1 — Corneat Vision, Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QWUProsthesis, Eyelid Spacer/Graft, Polymer1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K223074CorNeat EverPatchCorneat Vision, Ltd. · 20233 recalls

The one decision as Corneat Vision, Ltd. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K223074CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x…Aug 18, 2025Class II
  • K223074EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm…Aug 18, 2025Class II
  • K223074CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x…Oct 16, 2024Class II