EverPatch+ 1044002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI G16010440020), received between Apr 21, 2025 and Aug 22, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  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 REQ

  Patient problems: Wound Dehiscence

  MAUDE report 22870084 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Erosion; Wound Dehiscence

  MAUDE report 21877966 ↗