EX-PRESS® P-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380650704931), received between Jun 16, 2021 and Jul 17, 2025 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Obstruction of Flow; Obstruction of Flow

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER THE GLAUCOMA FILTRATION DEVICE IMPLANTATION, ELEVATED INTRAOCULAR PRESSURE (IOP) OF 40 MMHG WAS NOTED ON POST-OPERATIVE DAY ONE. THE SHUNT WAS OBSERVED TO BE IN POSITION IN THE ANTERIOR CHAMBER ON GONIOSCOPY. OCULAR MASSAGE AND LASER SUTURE LYSIS WERE ATTEMPTED; HOWEVER, DUE TO THE FAILURE OF THE SHUNT, A DECISION WAS MADE TO PROCEED WITH SURGICAL REVISION. THE EXISTING SHUNT WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. THE PATIENT'S ISSUE WAS SUBSEQUENTLY RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 22532696 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED VIA RETROSPECTIVE CLINICAL TRAIL STUDY THAT A PATIENT UNDERWENT SURGICAL INTERVENTION FOR THE LEFT EYE. THE INCIDENT HAS BEEN RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 20036678 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A GLAUCOMA SHUNT IMPLANT PROCEDURE, THE PATIENT UNDERWENT TRABECULECTOMY. ACCORDING TO THE CLINICAL RESEARCHER, THE EVENT WAS RELATED TO THE DEVICE. THE PATIENT'S WAS CONDITION RECOVERED.

  Patient problems: Insufficient Information

  MAUDE report 20017336 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL STUDY WAS REPORTED FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, THE INTRA OCULAR PRESSURE WAS ELEVATED MORE THAN 10MMHG FROM BASELINE WHICH WAS 18MMHG. THE EVENT WAS RELATED TO THE DEVICE AND SEVERITY WAS MODERATE. THIS LEADS TO THE SURGICAL INTERVENTION OF TRABECULECTOMY. THE PATIENT ISSUES WERE RESOLVED AND THE INTRA OCULAR PRESSURE DECREASED TO 12MMHG AND NICE BLEB ELEVATION. THE SAME PATIENT DEVELOPED BLEBITIS AND HYPOTONY MACULOPATHY (04MMHG) DUE TO OVERFILTRATION. THIS LEADS TO ANOTHER SURGICAL INTERVENTION OF IMPLANTING A NON-COMPANY GLAUCOMA DRAINAGE DEVICE ALONG WITH PLACEMENT OF TUTOPLAST SCLERAL PATCH GRAFT AND BLEB REVISION. THE INTRA OCULAR PRESSURE DECREASED TO 10MMHG AFTER THIS SURGICAL INTERVENTION AND PATIENT ISSUES WERE RESOLVED.

  Patient problems: Inflammation; Intraocular Pressure Decreased; Intraocular Pressure Increased

  MAUDE report 19929857 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL STUDY WAS REPORTED FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, THE INTRA OCULAR PRESSURE WAS ELEVATED MORE THAN 10MMHG FROM BASELINE WHICH WAS 19MMHG. THE EVENT WAS RELATED TO THE DEVICE, TEST PROCEDURE AND SEVERITY WAS MODERATE. THIS LEADS TO THE SURGICAL INTERVENTION OF IMPLANTING A NON-COMPANY GLAUCOMA DRAINAGE DEVICE ALONG WITH PLACEMENT OF TUTOPLAST SCLERAL PATCH GRAFT. THE PATIENT ISSUES WERE RESOLVED AND THE INTRA OCULAR PRESSURE DECREASED TO 06MMHG.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 19929723 ↗
• MalfunctionJul 22, 2024Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING GLAUCOMA SHUNT IMPLANT PROCEDURE, INSERTER HAD ISSUE AND SHUNT HAD TO BE REMOVED. ADDITIONAL INFORMATION RECEIVED STATING PHYSICIAN INSERTED THE SHUNT INTO THE PATIENT'S LEFT EYE BUT THE SHUNT WAS NOT SUPPORTED AND THE TIP WAS EMBEDDED IN THE IRIS. SHUNT REMAINED IN THE EYE, AND PHYSICIAN WAS NOT ABLE TO REMOVE AND REINSERTED THE SHUNT. SHUNT REMOVAL AND REPLACEMENT WAS PLANNED. ADDITIONAL INFORMATION RECEIVED STATING GLAUCOMA SHUNT WAS EXPLANTED 12 DAYS AFTER THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19793741 ↗
• MalfunctionMay 16, 2023Failure to Eject; Failure to Eject

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY THE SHUNT WOULD NOT DEPLOY. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT'S LEFT EYE WAS INVOLVED. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED AND NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. THE PATIENT DID NOT EXPERIENCE ANY ISSUES AS A RESULT OF THE EVENT AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16938046 ↗
• MalfunctionMar 31, 2023Ejection Problem; Ejection Problem

  A OTHER HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION WHEN THE SHUNT WAS INSERTED INTO THE SPACE IT CAME OUT. THE DEVICE WAS REMOVED AND REPLACED WITH NEW ONE. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654615 ↗
• MalfunctionDec 28, 2022Failure to Deliver; Failure to Deliver

  A FACILITY REPRESENTATIVE REPORTED THAT DURING A GLAUCOMA FILTRATION DEVICE IMPLANTATION, THE DEVICE DID NOT EJECT. ADDITIONAL INFORMATION WAS RECEIVED ND STATED THAT, THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059166 ↗
• MalfunctionDec 20, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NURSE REPORTED THAT DURING A GLAUCOMA FILTRATION DEVICE IMPLANTATION, DEVICE FAILED TO UNLOAD. THERE WAS A PATENT CONTACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044387 ↗
• MalfunctionAug 19, 2021Failure to Deliver; Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT GLAUCOMA FILTRATION DEVICE WITH A DESCRIPTION OF, DID NOT DEPLOY CORRECTLY. ADDITIONAL INFORMATION WAS RECEIVED GAVE CORRECTED DATE OF EVENT, SX COMPLETED W/ A NEW SHUNT; ITEM WAS MAILED IN SO SN IS NOT AVAILABLE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342199 ↗
• InjuryJun 16, 2021Unstable; Unstable

  A CUSTOMER REPORTED THE SHUNT FOUND TO BE IN AN AWKWARD POSITION DURING IMPLANTATION. THE SURGERY SITE WAS OPENED AND IT WAS FOUND THAT SCLERA WAS TORN AND THE SHUNT WAS UNSTABLE. THE SHUNT WAS REMOVED DURING THE SAME PROCEDURE AND THE CASE WAS CONVERTED TO BE A TRABECULECTOMY. NO PATIENT INJURY WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12012471 ↗