Recall Z-0040-2026— CORNEAT VISION, LTD.
Class II · Ongoing
Class II FDA medical device recall by CORNEAT VISION, LTD., initiated 2025-08-18. It names one FDA 510(k) clearance: K223074. 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. Reason: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch..
- Recalling firm
- CORNEAT VISION, LTD.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-18
- Firm location
- Ra'Anana, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Data sourced from openFDA. This site is unofficial and independent of the FDA.