Class 2 Device Recall EverPatch

• Date Initiated by Firm: August 18, 2025
• Date Posted: October 03, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0040-2026
• Recall Event ID: 97463
• 510(K)Number: K223074
• Product Classification: Prosthesis, eyelid spacer/graft, polymer - Product Code QWU
• Product: 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
• Code Information: All Lots/ UDI: G16010440020
• FEI Number: 3029772936
• Recalling Firm/ Manufacturer: CORNEAT VISION, LTD.; 4, Ha-Sheizaf; Ra'Anana Israel
• Manufacturer Reason for Recall: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: On August 18, 2025, CorNeat Vision, Ltd. issued a "Urgent: Medical Device Recall" Notification to affected consignees via E-Mail. CorNeat ask consignees to take the following actions: 1. Review inventory, Quarantine and Discontinue use of All Lots of the CorNeat EverPatch and/or EverPatch+. 2. Please discard any unused product. 3. Eyecare providers should continue to monitor patients who have had CorNeat EverPatch and/or EverPatch+ implanted at the follow-up frequency necessary to detect signs of wound dehiscence or conjunctival thinning/erosion. 4. Patients should be instructed to seek prompt follow-up if they experience any signs or symptoms consistent with this complication. 5. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 6. Please fill in the MEDICAL DEVICE RECALL RETURN RESPONSE form at www.corneat.com/everpatch-recall or fill in the attached form and forward to CorNeat Vision by email to complaints@corneat.com .
• Quantity in Commerce: 180 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = QWU