| 2025-08-18 |
Class II
|
Ongoing |
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, S… |
— |
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. |
| 2025-08-18 |
Class II
|
Ongoing |
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. |
| 2024-10-16 |
Class II
|
Ongoing |
Z-2537-2025 |
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX o… |
— |
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence. |