MAUDE Adverse Event Report: CORNEAT VISION, LTD. EVERPATCH; PROSTHESIS, EYELID SPACER/GRAFT, POLYMER

Model Number	1007691
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On august 18, 2025, corneat received notification of a case of wound dehiscence involving the corneat everpatch.A patient with a history of chronic angle-closure glaucoma underwent implantation of an ahmed glaucoma valve (agv) on (b)(6) 2024.The patient subsequently required agv revision surgery on (b)(6) 2024 for tube exposure, at which time the agv was covered with a corneat everpatch.Approximately 4.5 months following implantation of corneat everpatch, the conjunctival wound dehisced, and the corneat everpatch was partially exposed.The patient was treated with a topical antibiotic.No surgical revision was performed.No permanent impairment, including vision loss, was observed during the 18-month postoperative period.
Additional Manufacturer Narrative
The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.The implanted device was not available for evaluation.The current device instructions for use identifies the following possible complications: "detachment of the device from surrounding tissue in case of trauma or when chronic inflammation is not addressed"; and "conjunctival retraction or wound dehiscence, which may lead to exposure of the device and could require a corrective procedure".Manufacturer reference#: (b)(4).

• Brand Name: EVERPATCH
• Common Device Name: PROSTHESIS, EYELID SPACER/GRAFT, POLYMER
• Manufacturer (Section D): CORNEAT VISION, LTD.; 4 hasheizaf st.; raanana, central 43664 11; IS 4366411
• Manufacturer (Section G): CORNEAT VISION, LTD.; 4 hasheizaf st.; raanana, central 43664 11; IS 4366411
• Manufacturer Contact: benjamin bernstein ; 4 hasheizaf st.; raanana, central 43664-11 ; IS 4366411
• MDR Report Key: 23052078
• Report Number: 3029772936-2025-00006
• Device Sequence Number: 9824964
• Product Code: QWU
• UDI-Device Identifier: G16010362950
• UDI-Public: +G16010362950/$20230713/14D202501131
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K223074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2025
• Device Model Number: 1007691
• Device Catalogue Number: 1036295
• Device Lot Number: 20230713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AHMED GLAUCOMA VALVE (REVISION).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White