Z-0039-2026 Class II Ongoing

Recalled by CORNEAT VISION, LTD. — Ra'Anana

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