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

Model Number	1007691
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	04/24/2024
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 root cause investigation is underway and the findings will be provided in a supplemental report.Manufacturer reference #: (b)(4).
Event or Problem Description
A patient underwent glaucoma surgery on (b)(6) 2024 with implantation of a baerveldt glaucoma implant where the corneat everpatch was used to reinforce the sclera and aid the physical reconstruction of the ocular surface.During surgery, the everpatch was not visible which made it difficult to perform laser lysis.One day postoperatively the patient presented with an intraocular pressure (iop) of 50 mmhg.On (b)(6) 2024, the baerveldt device was explanted and replaced with an ahmed glaucoma shunt.Follow-up was requested from the surgeon who reports the patient may have lost vision.Additional follow-up will be requested.
Additional Manufacturer Narrative
Manufacturer reference#: (b)(4).
Event or Problem Description
Additional patient follow-up was requested from the surgeon on august 29, 2024, september 5, 2024, and september 8, 2024, with no additional information received.

• 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: 19370667
• Report Number: 3029772936-2024-00002
• Device Sequence Number: 7509694
• 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
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 04/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 11/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BAERVELDT GLAUCOMA IMPLANT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male