CORNEAT VISION, LTD.
FDA Regulatory Profile
CORNEAT VISION, LTD. appears in FDA public data with 3 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0039-2026, Class II) was initiated on August 18, 2025. Its most recent 510(k) clearance was granted on June 2, 2023.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0039-2026 | Class II | CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 | August 18, 2025 |
| Z-0040-2026 | Class II | EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x | August 18, 2025 |
| Z-2537-2025 | Class II | CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 | October 16, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K223074 | CorNeat EverPatch | June 2, 2023 |