Corneat Vision, Ltd.
Raanana, IL
Corneat Vision , Ltd. appears in FDA device records in Raanana, IL. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Corneat Vision, Ltd. in 2023.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0040-2026 | EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202 | Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. | Class II | Open, Classified | |
| Z-0039-2026 | CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m | Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. | Class II | Open, Classified | |
| Z-2537-2025 | CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only | Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain