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Recall Observatory FDA recall evidence

Device product

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only

Z-2537-2025

October 16, 2024

Class II

Product summary

Firm
CORNEAT VISION, LTD.
Event
Event 97281
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2537-2025

Official wording

Reason: Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.

Code information: UDI-DI: G16010362950

Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Argentina, Israel, Hong Kong.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.