Device product
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
Z-0040-2026
Product summary
- Event
- Event 97463
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 180 units
- Official record key
device-enforcement:Z-0040-2026
Official wording
Reason: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Code information: All Lots/ UDI: G16010440020
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.
Derived failure modes
-
Unknown
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.