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

Model Number	1007691
Medical Device Problem Codes	Use of Device Problem (1670); Expulsion (2933)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
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 extruded device was not available for evaluation.The instructions for use effective at the time of use included a contraindication stating the "corneat everpatch should not be used in surgical sites where active inflammation of any cause is present, or sites with poor perfusion." implantation of the corneat everpatch was contraindicated in this patient based on their history of poor ocular surface wound healing.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).
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 neovascular glaucoma, diabetes, and poor ocular surface wound healing underwent implantation of an ahmed glaucoma valve (agv) on (b)(6) 2023.The patient subsequently required agv revision surgery on (b)(6) 2023.On (b)(6) 2024, the agv was explanted and replaced with an ahmed clearpath glaucoma drainage device which was covered with a corneat everpatch.Approximately one month following implantation of corneat everpatch, the conjunctival wound dehisced, and the corneat everpatch spontaneously extruded from the eye.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.

• 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: 23049356
• Report Number: 3029772936-2025-00005
• Device Sequence Number: 18558225
• 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
• Device Explanted 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 CLEARPATH GLAUCOMA DRAINAGE DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White