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.
What this means for you
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.
- Hazard
- wound-dehiscence
- device-exposure
- implant
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
Distributed nationwide across the United States.
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