Recall Z-0039-2026— CORNEAT VISION, LTD.

Class II · Ongoing

Class II FDA medical device recall by CORNEAT VISION, LTD., initiated 2025-08-18. It names one FDA 510(k) clearance: K223074. Product: CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m. Reason: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch..

Recalling firm
CORNEAT VISION, LTD.
Classification
Class II
Status
Ongoing
Initiated
2025-08-18
Firm location
Ra'Anana, Israel

510(k) clearances named in this recall

1 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

Reason for recall

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

Data sourced from openFDA. This site is unofficial and independent of the FDA.