MAUDE Adverse Event Report: CORNEAT VISION, LTD. CORNEAT 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	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The everpatch remains implanted in the patient and is not available for evaluation by the manufacturer.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.The patch was well integrated with the conjunctiva and there is no information to suggest a device malfunction.The surgeon suspects there could be other patient-related medical considerations that may have predisposed this event, but the exact cause of the event is not known.Conjunctival dehiscence is a common postoperative adverse event and an inherent risk of glaucoma drainage device implantation.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The device instructions for use identifies the following possible complication: detachment of the device from surrounding tissue in case of trauma or when chronic inflammation is not addressed.Manufacturer reference (b)(4).
Event or Problem Description
A patient underwent glaucoma surgery in late (b)(6) /early (b)(6) 2024 with implantation of an ahmed glaucoma valve where the corneat everpatch was used to reinforce the sclera and aid the physical reconstruction of the ocular surface.Approximately 2 months postoperatively the surgeon observed conjunctival dehiscence with partial exposure of the everpatch.Although there was no tube exposure and no wound leak, the surgeon elected to schedule corrective surgery to rotate the flap inferiorly and re-suture to cover the exposed area.After the intervention, the surgeon reported observing that the patch was well integrated with the conjunctiva.The sutures were not directly placed over the patch.Additional patient follow-up was requested from the surgeon and on (b)(6) 2024 (3 weeks after surgical intervention), the surgeon responded that the patient has been doing well.

• Brand Name: CORNEAT 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: 19295720
• Report Number: 3029772936-2024-00001
• Device Sequence Number: 7340032
• Product Code: QWU
• UDI-Device Identifier: G16010362950
• UDI-Public: G16010362950
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K223074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2024

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: 04/08/2024
• Initial Report FDA Received Date: 05/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male