BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERPATCH+

    MDR report key: 22870084 · Received August 22, 2025

    Report

    Report Number
    3029772936-2025-00003
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 21, 2025
    Manufacturer
    CORNEAT VISION, LTD.
    Product Code
    QWU
    UDI-DI
    G16010440020
    PMA / PMN Number
    K223074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557988 EVERPATCH+ PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION, LTD. 20250113 G16010440020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention