Z-0039-2026 Class II Ongoing
FDA device recall Z-0039-2026 was initiated by CORNEAT VISION, LTD. on August 18, 2025 and is designated Class II. Reason for recall: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. The recall status is ongoing. Affected quantity: 630 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 15, 2025
- Initiation Date
- August 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
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
All Lots/ UDI: G16010362950