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Prosthesis, Eyelid Spacer/Graft, Polymer

FDA product code QWU · Class 2 · Ophthalmic

2
Registered devices
33
Adverse events
3
Recalls
1
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-08-18CORNEAT VISION, LTD.Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
2025-08-18CORNEAT VISION, LTD.Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
2024-10-16CORNEAT VISION, LTD.Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.