FDA Medical Device Recalls (openFDA)
CORNEAT VISION, LTD.: CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m
- Recall number
- Z-0039-2026
- Recalling firm
- CORNEAT VISION, LTD.
- Product
- CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m
- Status
- Open, Classified
- Initiated
- 2025-08-18
- Posted
- 2025-10-03
- Terminated
- not on file
- Reason
- Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
- Root cause
- Unknown/Undetermined by firm
- Action
- On August 18, 2025, CorNeat Vision, Ltd. issued a "Urgent: Medical Device Recall" Notification to affected consignees via E-Mail. CorNeat ask consignees to take the following actions: 1. Review inventory, Quarantine and Discontinue use of All Lots of the CorNeat EverPatch and/or EverPatch+. 2. Please discard any unused product. 3. Eyecare providers should continue to monitor patients who have had CorNeat EverPatch and/or EverPatch+ implanted at the follow-up frequency necessary to detect signs of wound dehiscence or conjunctival thinning/erosion. 4. Patients should be instructed to seek prompt follow-up if they experience any signs or symptoms consistent with this complication. 5. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 6. Please fill in the MEDICAL DEVICE RECALL RETURN RESPONSE form at www.corneat.com/everpatch-recall or fill in the attached form and forward to CorNeat Vision by email to complaints@corneat.com .
- Quantity
- 630 units
- Distribution
- 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.
- Lot, serial or model codes
- All Lots/ UDI: G16010362950
- 510(k) numbers
- ["K223074"]
- PMA numbers
- not on file
- Product code
- QWU
- Firm FEI
- 3029772936
- Firm city
- Ra'Anana
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28