Medical device recalls Moderate risk

CORNEAT VISION, LTD. recalls EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle,…

Recall date
August 18, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0040-2026
FDA classification
Class II
Brand / firm
CORNEAT VISION, LTD.
Sold / distributed
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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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