Scleral Reinforcement Patches Recalled for Surgical Wound Separation Risk
EverPatch+ scleral reinforcement patches are recalled because the conjunctival wound closure may separate, exposing the surgical patch. This affects 180 units distributed across the US and internationally.
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: This is an FDA Class II device recall with complaints identifying a surgical complication (conjunctival wound dehiscence). The hazard represents a risk-of-harm scenario for a critical ophthalmic implant, though no explicit injury reports are documented in the source material.
Plain-English summary
EverPatch+ (REF: 1044002), a permanent scleral reinforcement patch used in eye surgery, is being recalled. All lots are affected (UDI: G16010440020). Complaints have identified that the conjunctival wound may separate, exposing the surgical patch.
The recall affects 180 units distributed worldwide, including across US states (Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin, plus Washington DC) and internationally to Japan, Israel, Argentina, and Hong Kong.
Patients who received this device should consult their ophthalmologist regarding the recall.
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
- patch-exposure
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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