Scleral reinforcement matrix recalled after complaints of early patch exposure
CorNeat Vision is recalling 180 EverPatch+ units after reviewed complaints identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: complaints identify early exposure of an implanted ocular patch, a clinical risk with no injury count stated.
Plain-English summary
EverPatch+, REF 1044002, a permanent scleral reinforcement matrix supplied as a 5.0mm x 8.5mm shield and a 5.0mm x 6.5mm rectangle, sterile, is being recalled.
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
The recall covers 180 units across all lots, UDI G16010440020, distributed worldwide including in Arizona, California, Colorado, Connecticut, the District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas and Massachusetts among other states. The FDA has classified the action as Class II.
Surgeons and facilities holding the product should follow CorNeat Vision's instructions.
The recalled product
- 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
- Manufacturer
- CORNEAT VISION, LTD.
- Affected units
- 180
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots/ UDI: G16010440020
Distribution
Part of a larger recall action
This product is one of 2 recalled by CORNEAT VISION, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · CORNEAT VISION, LTD.
See all →- HighOcular surgical matrix recalled after complaints of early patch exposure
FDA (Devices) · 2025-10-15
- ModerateSurgical matrix patches recalled for labeling correction on wound dehiscence management
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