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Recall Observatory FDA recall evidence

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

August 18, 2025

Class II

Product summary

Firm
CORNEAT VISION, LTD.
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

    reason.no_named_rule · v1.0.0

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