FDA (Devices) recall action 97463
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CorNeat Vision is recalling 180 EverPatch+ units after reviewed complaints identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
CorNeat Vision is recalling 630 CorNeat EverPatch units after reviewed complaints identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.