CORNEAT VISION, LTD. recalls CorNeat EverPatch
Reason for recall
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX onlyUDI-DIUDI-DI G16010362950
What the firm is doing
On October 16-17, 2024, Corneat Vision provided customers with an email containing important information concerning the device safety and efficacy related CorNeat EverPatch. Customers were informed that the IFUs were modified to include conditions that may impair healing and reduce he effectiveness of the EverPatch. Surgical practices were advised to maximize success rate.
DistributionShow detailsHide
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Argentina, Israel, Hong Kong.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2537-2025
- FDA 510(k) clearance · K223074The device's official FDA premarket clearance record
- FDA device classification · QWUOfficial FDA classification for this device type
- CFR regulation · 21 CFR 886.3130The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find CORNEAT VISION, LTD.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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