CorNeat EverPatch 1007691Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI G16010362950), received between May 12, 2024 and Sep 15, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AUGUST 18, 2025, CORNEAT RECEIVED NOTIFICATION OF A CASE OF WOUND DEHISCENCE INVOLVING THE CORNEAT EVERPATCH. A PATIENT WITH A HISTORY OF CHRONIC ANGLE-CLOSURE GLAUCOMA UNDERWENT IMPLANTATION OF AN AHMED GLAUCOMA VALVE (AGV) ON (B)(6) 2024. THE PATIENT SUBSEQUENTLY REQUIRED AGV REVISION SURGERY ON (B)(6) 2024 FOR TUBE EXPOSURE, AT WHICH TIME THE AGV WAS COVERED WITH A CORNEAT EVERPATCH. APPROXIMATELY 4.5 MONTHS FOLLOWING IMPLANTATION OF CORNEAT EVERPATCH, THE CONJUNCTIVAL WOUND DEHISCED, AND THE CORNEAT EVERPATCH WAS PARTIALLY EXPOSED. THE PATIENT WAS TREATED WITH A TOPICAL ANTIBIOTIC. NO SURGICAL REVISION WAS PERFORMED. NO PERMANENT IMPAIRMENT, INCLUDING VISION LOSS, WAS OBSERVED DURING THE 18-MONTH POSTOPERATIVE PERIOD.

  Patient problems: Wound Dehiscence

  MAUDE report 23052078 ↗
• InjurySep 15, 2025Use of Device Problem; Expulsion; Use of Device Problem; Expulsion

  ON AUGUST 18, 2025, CORNEAT RECEIVED NOTIFICATION OF A CASE OF WOUND DEHISCENCE INVOLVING THE CORNEAT EVERPATCH. A PATIENT WITH A HISTORY OF NEOVASCULAR GLAUCOMA, DIABETES, AND POOR OCULAR SURFACE WOUND HEALING UNDERWENT IMPLANTATION OF AN AHMED GLAUCOMA VALVE (AGV) ON (B)(6) 2023. THE PATIENT SUBSEQUENTLY REQUIRED AGV REVISION SURGERY ON (B)(6) 2023. ON (B)(6) 2024, THE AGV WAS EXPLANTED AND REPLACED WITH AN AHMED CLEARPATH GLAUCOMA DRAINAGE DEVICE WHICH WAS COVERED WITH A CORNEAT EVERPATCH. APPROXIMATELY ONE MONTH FOLLOWING IMPLANTATION OF CORNEAT EVERPATCH, THE CONJUNCTIVAL WOUND DEHISCED, AND THE CORNEAT EVERPATCH SPONTANEOUSLY EXTRUDED FROM THE EYE. THE PATIENT WAS TREATED WITH A TOPICAL ANTIBIOTIC. NO SURGICAL REVISION WAS PERFORMED. NO PERMANENT IMPAIRMENT, INCLUDING VISION LOSS, WAS OBSERVED DURING THE 18-MONTH POSTOPERATIVE PERIOD.

  Patient problems: Wound Dehiscence

  MAUDE report 23049356 ↗
• InjuryNov 5, 2024Migration; Migration

  CORNEAT RECEIVED A VOLUNTARY MEDWATCH REPORT (#MW5159337) WHICH STATED: "PATIENT UNDERWENT IMPLANTATION OF GLAUCOMA TUBE SHUNT SURGERY IN THE LEFT EYE ON (B)(6) AND A CORNEAT EVERPATCH WAS USED TO COVER THE TUBE SHUNT. ON (B)(6) SHE DEVELOPED OCULAR DISCOMFORT AND LOOKED IN THE MIRROR AND SAW THE EVERPATCH HAD DISLOCATED ANTERIORLY AND WAS PARTIALLY COVERING HER CORNEA. SHE PRESENTED TO THE EMERGENCY ROOM FOR THIS AND THEN WAS SCHEDULED FOR URGENT TUBE SHUNT REVISION TO PREVENT INFECTION/ENDOPHTHALMITIS. THIS WAS DONE BY EXPLANTING THE EVERPATCH AND REPLACING IT WITH AN IRRADIATED CORNEAL PATCH AND CLOSING THE CONJUNCTIVA OVER IT." THIS CASE IS RELATED TO MDR #3029772936-2024-00004 AND PROVIDES ADDITIONAL DETAILS ON A SPECIFIC PATIENT FROM THE REPORTED CASES IN THE REFERENCED MDR.

  Patient problems: Discomfort; Wound Dehiscence

  MAUDE report 20606474 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CORNEAT RECEIVED A VOLUNTARY MEDWATCH REPORT (#MW5159327) WHICH STATED: "PATIENT UNDERWENT REVISION SURGERY FOR EXPOSED TUBE SHUNT IN THE LEFT EYE, WHICH INVOLVED COVERING THE TUBE WITH A CORNEAT EVERPATCH AND CLOSING CONJUNCTIVA OVER IT. BY POST-OP WEEK #4, IT WAS NOTED THAT THE CONJUNCTIVA HAD RETRACTED AND EXPOSED THE EVERPATCH. THE PATIENT THEREFORE UNDERWENT ANOTHER REVISION SURGERY ON (B) (6) 2024 TO PREVENT INFECTION, DURING WHICH THE EVERPATCH WAS EXPLANTED AND REPLACED WITH AN IRRADIATED DONOR CORNEAL TISSUE." THIS CASE IS RELATED TO MDR #3029772936-2024-00004 AND PROVIDES ADDITIONAL DETAILS ON A SPECIFIC PATIENT FROM THE REPORTED CASES IN THE REFERENCED MDR.

  Patient problems: Wound Dehiscence

  MAUDE report 20584618 ↗
• InjuryOct 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON SEPTEMBER 24, 2024, THE MANUFACTURER BECAME AWARE OF A REPORTABLE EVENT INVOLVING THE EVERPATCH DEVICE WHICH WAS IMPLANTED WITH GLAUCOMA TUBE SHUNT. APPROXIMATELY ONE-WEEK POSTOPERATIVELY THE PATIENT PRESENTED WITH WOUND DEHISCENCE AND EXPOSURE OF THE EVERPATCH. THE PATIENT UNDERWENT SURGICAL REVISION. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN ON (B)(6) 2024 AND (B)(6) 2024.

  Patient problems: Wound Dehiscence

  MAUDE report 20527823 ↗
• InjuryOct 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON SEPTEMBER 5, 2024, THE MANUFACTURER BECAME AWARE OF SEVERAL CASES INVOLVING THE EVERPATCH DEVICES WHICH WERE IMPLANTED IN CONJUNCTION WITH GLAUCOMA TUBE SHUNTS, WHERE THE PATIENTS UNDERWENT SURGICAL REVISIONS DUE TO EXPOSURES. NO SPECIFIC PATIENT OR DEVICE INFORMATION WAS PROVIDED. ADDITIONAL PATIENT FOLLOW-UP WAS REQUESTED ON SEPTEMBER 5, 2024 AND SEPTEMBER 29, 2024. AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN RECEIVED IN ORDER TO UNDERSTAND THE DETAILS OF THE REPORTABLE EVENTS WHERE SECONDARY SURGICAL INTERVENTION WAS PERFORMED.

  Patient problems: Wound Dehiscence

  MAUDE report 20349511 ↗
• InjuryOct 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, A PATIENT WITH GLAUCOMA UNDERWENT IMPLANTATION OF THE AHMED GLAUCOMA VALVE IN THE RIGHT EYE AND THE EVERPATCH DEVICE WAS USED TO COVER THE TUBE (SULCUS TUBE PLACEMENT). A FORNIX-BASED FLAP WAS CREATED, AND THE GLAUCOMA VALVE WAS IMPLANTED IN THE INFERIOR NASAL QUADRANT AND SECURED WITH VICRYL INTERRUPTED SUTURES. THE SEIDEL TEST WAS NEGATIVE AT THE END OF SURGERY (I.E., NO WOUND LEAK). APPROXIMATELY 2 WEEKS POSTOPERATIVELY, THE PATIENT PRESENTED WITH WOUND DEHISCENCE AND EXPOSURE OF 2/3 OF THE EVERPATCH. THE PATIENT UNDERWENT SURGICAL REVISION WITH EXTENSIVE DISSECTION AND CONJUNCTIVAL MOBILIZATION. THE EVERPATCH WAS CORRECTED BY ADVANCING HEALTHY CONJUNCTIVA TO COVER THE ENTIRE PATCH, ENSURING CLOSURE WITHOUT UNDUE TENSION AND REINFORCED WITH TWO 10-0 NYLON MATTRESS SUTURES AT THE LIMBUS. THE PATIENT PRESENTED WITH RECURRENT WOUND DEHISCENCE 2 WEEKS FOLLOWING THE REVISION WITH EXPOSURE OF 1/3 OF THE EVERPATCH. THE PATIENT IS CURRENTLY STABLE WITH A NEGATIVE SEIDEL TEST (I.E., NO WOUND LEAK). FURTHER REVISION SURGERY IS NOT VIABLE DUE TO THE CURRENT STATE OF THE CONJUNCTIVA, AND THE SURGEON IS MONITORING THE PATIENT FOR RE-EPITHELIALIZATION. THE SURGEON SUSPECTS THE

  Patient problems: Wound Dehiscence

  MAUDE report 20349419 ↗
• InjuryOct 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON SEPTEMBER 1, 2024, THE MANUFACTURER BECAME AWARE OF SERIOUS INJURIES INVOLVING THE EVERPATCH DEVICES WHICH WERE IMPLANTED IN CONJUNCTION WITH GLAUCOMA TUBE SHUNTS. THE SURGEON USES A RUNNING 8-0 OR 9-0 VICRYL SUTURE ALONG THE ENTIRE LENGTH OF THE INCISION, INCLUDING THE ENTIRE LIMBAL PORTION AND 2 ANCHORING SUTURES ARE PLACED IN THE EVERPATCH. THREE PATIENTS PRESENTED WITH POSTOPERATIVE EXPOSURE OF THE EVERPATCH WHERE THE ANTERIOR EDGE OF THE EVERPATCH BECAME EXPOSED; THE PATIENTS UNDERWENT SURGICAL REVISION FOR EVERPATCH REPAIR WHICH CONSISTED OF TRIMMING THE ANTERIOR EDGE WITH SHARP WESCOTT SCISSORS. PREOPERATIVELY, ONE PATIENT HAD A VERY THIN CONJUNCTIVA AND ABSENT OR VERY THIN ANTERIOR TENON'S CAPSULE; IN RETROSPECT THIS PATIENT MAY NOT HAVE BEEN A GREAT CANDIDATE FOR THE EVERPATCH. ADDITIONAL INFORMATION WAS REQUESTED ON SEPTEMBER 16, 2024.

  Patient problems: Wound Dehiscence

  MAUDE report 20349372 ↗
• InjurySep 30, 2024Migration; Migration

  ON (B)(6) 2024, A PATIENT WITH NEOVASCULAR GLAUCOMA UNDERWENT IMPLANTATION OF THE AHMED GLAUCOMA VALVE IN THE RIGHT EYE AND THE EVERPATCH DEVICE WAS USED TO COVER THE TUBE WHERE THE TUBE WAS PLACED IN THE CILIARY SULCUS. 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 INTERRUPTED SUTURES. AT THE 3-MONTH POSTOPERATIVE EXAMINATION ON (B)(6) 2024, EVERYTHING LOOKED GOOD INCLUDING THE EVERPATCH. HOWEVER, AT THE 6-MONTH EXAMINATION ON (B)(6) 2024, THE PATIENT PRESENTED WITH EXPOSURE OF THE ANTERIOR TEMPORAL CORNER OF THE EVERPATCH. THERE WAS NO WOUND LEAK (SEIDEL NEGATIVE). ON (B)(6) 2024, TUBE REVISION SURGERY WAS PERFORMED; THE EVERPATCH WAS EXPLANTED AND REPLACED WITH A CORNEAL PATCH GRAFT. DURING EXPLANTATION, THE EVERPATCH WAS NOT INCORPORATED INTO THE TENONS, EXCEPT FOR THE POSTERIOR 2 SUTURE HOLES AND POSTERIOR EDGE OF THE GRAFT. THE ENTIRE ANTERIOR PORTION OF THE OF THE PATCH WAS FREE AND MOBILE UNDER THE CONJUNCTIVA. THE TEMPORAL EDGE OF THE EVERPATCH WAS CLOSEST TO THE LIMBUS. THE SURGEO

  Patient problems: Wound Dehiscence

  MAUDE report 20340225 ↗
• InjurySep 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AUGUST 28, 2024, THE MANUFACTURER BECAME AWARE OF 2 SERIOUS INJURIES INVOLVING THE EVERPATCH DEVICES WHICH WERE IMPLANTED IN CONJUNCTION WITH GLAUCOMA TUBE SHUNTS. SPECIFICALLY, THE PATIENTS PRESENTED WITH WOUND DEHISCENCE, CONJUNCTIVAL RETRACTION, AND EXPOSURE OF THE EVERPATCH. BOTH PATIENTS UNDERWENT SURGICAL REVISION; ONE EVERPATCH WAS EXPLANTED AND REPLACED BY SCLERA AND ONE EVERPATCH WAS CORRECTED BY ADVANCING THE CONJUNCTIVA AND RE-SUTURING. BOTH PATIENTS ARE DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED ON SEPTEMBER 16, 2024.

  Patient problems: Wound Dehiscence

  MAUDE report 20328704 ↗
• InjurySep 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, A PATIENT UNDERWENT IMPLANTATION OF A GLAUCOMA DRAINAGE DEVICE WITH THE CORNEAT EVER PATCH TO COVER THE TUBE. THE CONJUNCTIVAL EDGE WAS SUTURED WITH A RUNNING VICRYL SUTURE. ONE WEEK POSTOPERATIVELY, THE EYE WAS NOT RE-EPITHELIALIZING AS EXPECTED AND THE PATIENT PRESENTED WITH CONJUNCTIVAL WOUND DEHISCENCE AND GRAFT EXPOSURE. SPECIFICALLY, WOUND DEHISCENCE EXPOSED THE ANTERIOR EDGE OF THE EVER PATCH, BUT THERE WAS NO TUBE EXPOSURE OR WOUND LEAK (SEIDEL NEGATIVE). REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REPLACE THE PATCH WITH CORNEAL TISSUE. ADDITIONAL PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON ON (B)(6) 2024.

  Patient problems: Wound Dehiscence

  MAUDE report 20286524 ↗
• InjuryMay 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  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.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 19370667 ↗
• InjuryMay 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT GLAUCOMA SURGERY IN LATE (B)(6) /EARLY (B)(6) 2024 WITH IMPLANTATION OF AN AHMED GLAUCOMA VALVE WHERE THE CORNEAT EVERPATCH WAS USED TO REINFORCE THE SCLERA AND AID THE PHYSICAL RECONSTRUCTION OF THE OCULAR SURFACE. APPROXIMATELY 2 MONTHS POSTOPERATIVELY THE SURGEON OBSERVED CONJUNCTIVAL DEHISCENCE WITH PARTIAL EXPOSURE OF THE EVERPATCH. ALTHOUGH THERE WAS NO TUBE EXPOSURE AND NO WOUND LEAK, THE SURGEON ELECTED TO SCHEDULE CORRECTIVE SURGERY TO ROTATE THE FLAP INFERIORLY AND RE-SUTURE TO COVER THE EXPOSED AREA. AFTER THE INTERVENTION, THE SURGEON REPORTED OBSERVING THAT THE PATCH WAS WELL INTEGRATED WITH THE CONJUNCTIVA. THE SUTURES WERE NOT DIRECTLY PLACED OVER THE PATCH. ADDITIONAL PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON AND ON (B)(6) 2024 (3 WEEKS AFTER SURGICAL INTERVENTION), THE SURGEON RESPONDED THAT THE PATIENT HAS BEEN DOING WELL.

  Patient problems: Wound Dehiscence

  MAUDE report 19295720 ↗