Medical Device Recall: Z-0039-2026

FDA Recalls dataset · Firm: CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2025-08-18 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0039-2026.

Recall Res Number
Z-0039-2026
FEI Number
3029772936
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2025-08-18
Date Posted
2025-10-03
Date Terminated
N/A
Product Code
QWU
Event Number
97463
Product Quantity
630 units
Product Description CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m

Reason for Recall Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

Action Details 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 .

Distribution Pattern 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.

Code Information / Serial Numbers All Lots/ UDI: G16010362950

Related Establishments / Registrations

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