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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