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

Catalog Number	1044002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erosion (1750)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient with glaucoma underwent implantation of the ahmed glaucoma valve in the right eye and the everpatch+ was used to cover the tube.A fornix-based flap was created and the glaucoma valve was implanted in the superior temporal quadrant; cautery was used intraoperatively to control bleeding and minimize scarring.Surgery was uneventful and the wound was closed with vicryl continuous sutures.Topical steroids were prescribed postoperatively (per standard of care).Within the first postoperative month, the patient presented with exposure of the conjunctiva over the everpatch+; however, there was no wound leak (i.E., seidel negative).On (b)(6) 2025, tube revision surgery was performed where the everpatch+ was explanted and replaced with a tutoplast.During explantation, the everpatch+ was not well adherent and was easily removed.The surgeon suspects that the patient's very thin conjunctiva (no tenon's) likely contributed to the conjunctival erosion.The patient has not experienced a loss of 2 or more lines of best corrected visual acuity (bcva) compared to baseline.
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 explanted device was discarded by the user and is not available for evaluation.An investigation is underway to evaluate the rate of wound dehiscence and exposure associated with everpatch+.Based on current data, this is the only known case of everpatch+ exposure.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".The current instructions for use also recommends "in the short term after surgery, more frequent follow-up visits should be conducted to ensure proper wound healing." 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: 21877966
• Report Number: 3029772936-2025-00002
• Device Sequence Number: 7865295
• Product Code: QWU
• UDI-Device Identifier: G16010440020
• UDI-Public: +G16010440020/$20250113/14D20270713X
• 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: 2025
• Device Explanted Year: 2025
• 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): 04/21/2025

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 Catalogue Number: 1044002
• Device Lot Number: 20250113
• 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: 03/24/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Race: Black Or African American