United StatesThe CorNeat EverPatch (REF 1036295, Permanent Tissue‑Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 μm, UDI G16010362950) and EverPatch+ (REF 1044002, Permanent Scleral Reinforcement Matrix 1 x 5.0 mm x 8.5 mm Shield / 1 x 5.0 mm x 6.5 mm Rectangle, sterile, UDI G16010440020) are being recalled. Reviewed complaints identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
What's being recalled
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
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
Recalling firm: Corneat Vision, LTD., Ra'Anana, Israel.
How to identify it
All Lots/ UDI: G16010362950 All Lots/ UDI: G16010440020
The hazard
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)