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

Catalog Number	1044002
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	07/22/2025
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 explanted devices were discarded by the user and are not available for evaluation.Based on the surgeon's description of the surgical technique, wound dehiscence is attributed to use error where the device was implanted directly under the conjunctival incision in all 3 cases.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).
Event or Problem Description
Corneat received information from an uninvolved third-party suggesting that a colleague had implanted 3 everpatch+ devices and observed wound dehiscence in all 3 cases.Additional information was requested from the third party and this enabled corneat to identify the implanting surgeon who was later contacted.The implanting surgeon confirmed observing wound dehiscence in 3 everpatch+ cases, clarifying that these patients selected for his first use of the device were some of his worst candidates in terms of their ocular surface health.The surgeon described his surgical technique as a limbal-based approach with the surgical incision 5 mm posterior to the limbus.Importantly, all surgical wounds were closed directly over the everpatch+, deviating from the everpatch+ instructions for use which specifies "the device should not be implanted directly under a conjunctival incision".Tenon was not closed independently, but rather secured to the peripheral sclera.Two cases exhibited exposure immediately due to wound dehiscence and one exposure was observed 6 weeks post implantation.Two patients underwent surgical revision and revision surgery is planned for the third patient.Corneat requested event details for each of these patients.Once additional information becomes available a follow-up report will be submitted.

• 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: 22870084
• Report Number: 3029772936-2025-00003
• Device Sequence Number: 9081475
• Product Code: QWU
• UDI-Device Identifier: G16010440020
• UDI-Public: +G16010440020/$20250113/14D20270713X
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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: 07/22/2025
• Initial Report FDA Received Date: 08/22/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown