FDA-Device2025-10-15Class II
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
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
180 units
Manufactured in
4, Ha-Sheizaf, Ra'Anana, Israel
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0040-2026Want us to check the next one for you?
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