CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m
Recall
- Recall Number
- Z-0039-2026
- Event Number
- 97463
- Firm
- CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel
- FEI Number
- 3029772936
- Product Code
- QWU
- Status
- Open, Classified
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- August 18, 2025
- Posted
- October 3, 2025
Description
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
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 [email protected] .
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.
630 units