FDA Device recall 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
- FDA Device
- Class II
- ongoing
- Published 2025-10-15
On 2025-10-15 the FDA classified a Class II recall of 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 by Corneat Vision, citing reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0040-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-18 |
| Published | 2025-10-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Corneat Vision |
| Distribution | US |
Product
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
Reason
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Identifiers
| code_info | All Lots/ UDI: G16010440020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0040-2026%22
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