Quick Facts at a Glance
- Recall Date
- August 18, 2025
- Hazard Level
- HIGH
- Brand
- CorNeat Vision
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CorNeat Vision
- Product type
- Permanent Tissue-Integrating Surgical Matrix
- Model numbers
- All Lots/ UDI: G16010362950
- Sizes
- 5.0 mm x 605 mm x 100 µm
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 18, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CORNEAT VISION, LTD. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
EverPatch is a surgical matrix intended to aid tissue integration during ocular procedures. It is used by surgeons in the operating room under medical supervision.
Why This Is Dangerous
If the conjunctival wound dehisces, the patch could become exposed prematurely, potentially complicating healing and necessitating additional procedures.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall may disrupt planned surgeries and require patients to undergo follow-up interventions. The issue creates safety and operational uncertainty for treatment teams.
Practical Guidance
How to identify if yours is affected
- Verify UDI on product labeling: All Lots/ UDI G16010362950
- Check packaging for recall notice and batch information
- Compare with the recall list to confirm eligibility
Where to find product info
UDI appears on the device labeling and patient device cards; the FDA recall page provides official details
What timeline to expect
Replacement or refund timelines typically 4-8 weeks after confirmation
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- File a complaint with the relevant regulatory body if the company is unresponsive
- Consult your surgeon for alternatives during the recall period
How to prevent similar issues
- Before future implants, verify recall status and product numbers with the supplier
- Ask clinicians to confirm lot numbers and UDI before use
- Keep records of all device lot numbers and recall notices
Documentation advice
Retain all recall notices, correspondence with the manufacturer, and any medical records related to the affected device
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Product Details
Model numbers: All Lots/ UDI: G16010362950. Sold worldwide through healthcare distributors and providers. Sold since: Unknown. Price: Unknown. Quantity: 630 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution including US states listed and Japan, Israel, Argentina, Hong Kong
- Hazard: conjunctival wound dehiscence leading to early patch exposure
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Safety Guide
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