Z-0040-2026 Class II Ongoing
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
- 180 units
Product Description
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
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: G16010440020