CLASS II ONGOING Device recall · Reported 15 Oct 2025 · FDA Enforcement Report
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix recalled
Corneat Vision is recalling EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix, distributed nationwide in the US. The recall was initiated on 18 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0040-2026
- FDA event ID
- 97463
- Recalling firm
- Corneat Vision, Ra'Anana
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Aug 2025
- FDA classified
- 3 Oct 2025
- Reported
- 15 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Aug 2025 | Recall initiated by company | |
| 3 Oct 2025 | Classified by FDA | +46 days |
| 15 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Product as listed by the FDA
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
Where it was distributed
Worldwide - US Nationwide distribution in the states of 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 and the countries of Japan, Israel, Argentina, Hong Kong.
Nationwide ArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIdahoIllinoisIndianaKansasMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth CarolinaNew York
Questions about this recall
Why was it recalled?
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Which lots are affected?
All Lots/ UDI: G16010440020
Where was it sold?
Worldwide - US Nationwide distribution in the states of 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 and the countries of Japan, Israel, Argentina, Hong Kong.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97463This product is part of a recall event; the main page for the event is CorNeat EverPatch recalled by Corneat Vision.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CorNeat EverPatch recalled by Corneat Vision | Corneat Vision | Other | Nationwide |
More recalls from Corneat Vision
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CorNeat EverPatch recalled by Corneat Vision | Corneat Vision | Other | Nationwide |
| Device | CLASS II | CorNeat EverPatch recalled by Corneat Vision | Corneat Vision | Other | Nationwide |
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| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |