FDA-Device2025-10-15Class II
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
CORNEAT VISION, LTD.
Hazard
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Sold states
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Japan, Israel, Argentina, Hong Kong.
Affected count
630 units
Manufactured in
4, Ha-Sheizaf, Ra'Anana, Israel
Products
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0039-2026Don't want to check this manually?
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