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
- Ophthalmic Surgical Patch
- Model numbers
- All Lots/ UDI: G16010440020
- 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 an implant used in ocular surgery to reinforce the sclera. Hospitals and surgeons order it for select patients needing scleral reinforcement. The device is sold worldwide and is sterile.
Why This Is Dangerous
If conjunctival tissue wounds dehisce, the patch can become exposed, which may require additional surgery or treatment.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Patients may experience surgical patch exposure, leading to additional medical intervention and scheduling delays. The recall could affect upcoming procedures and require supplier changes.
Practical Guidance
How to identify if yours is affected
- Check the patch reference 1044002.
- Verify UDI G16010440020 on All Lots.
- Confirm distribution through CORNEAT VISION channels.
Where to find product info
Recall notice and FDA enforcement page linked in sources. Manufacturer communications via email.
What timeline to expect
Refunds or replacements typically processed within 4-8 weeks after manufacturer acknowledgment.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer.
- File a complaint with the FDA or relevant regulatory body if no resolution is reached within a reasonable timeframe.
How to prevent similar issues
- Verify UDI and batch numbers before implants.
- Only purchase from authorized distributors.
- Monitor for recalls before surgical planning.
Documentation advice
Retain recall notices, emails, and medical records related to the implant and any corrective actions.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Brand: CORNEAT VISION Product: EverPatch+ Permanent Scleral Reinforcement Matrix patch REF: 1044002 UDI: G16010440020 Model: All Lots Quantity: 180 units Sold: Worldwide Recall date: 2025-08-18 Status: ACTIVE Distribution: Worldwide including AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI; Japan, Israel, Argentina, Hong Kong Manufacturer: CORNEAT VISION
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- All Lots UDI: G16010440020
- Worldwide distribution including 50 US states and select countries
- No injuries or incidents reported
- Stop use immediately; follow manufacturer recall instructions
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
