Ahmed™ Glaucoma Valve FP7Recalls & reported problems

Summary

The FDA's MAUDE database contains 266 adverse event reports that list this exact device (DI 00892064002119), received between May 3, 2016 and Sep 25, 2026 — classified as 203 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Device Issue” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 266 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  FP7 stopped functioning.

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

  MAUDE report 50899347 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERGONE AN AHMED TUBE IMPLANT BY DR (B)(6)/ (B)(6) ON (B)(6) 2026. DR (B)(6) PRIMED THE TUBE AND DID NOT NOTE OF ANY ABNORMALITIES. SURGERY WAS UNEVENTFUL. HOWEVER, PATIENT HAD PERSISTENT HYPOTONY POSTOPERATIVELY. (B)(6) 2026, POD 5, NOTED OVER-FILTERING TUBE VS PERITUBULAR LEAK (LARGE BLEB) IOP 2- HEALON GV INJECTED. THE PLATE WAS COVERED BY CONJ AND TUTOPLAST, WITH SUTURES INTACT AND WATERTIGHT WITH NO LEAKS. ON (B)(6) 2026, PATIENT RETURNED TO OT FOR TUBE LIGATION/STENTING KIV CONJ AUTOGRAFT INTRAOPERATIVE FINDINGS ON (B)(6) 2026 NOTED: OVER-FILTRATION, VALVE FAILURE, NO PERITUBE LEAK. SURGEONS STENTED THE TUBE PLATE JUNCTION WITH 4/0 PROLENE AND CLOSED THE WOUND IN THE MEANTIME, THE TEAM IS STILL MONITORING THE PATIENT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 25415041 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  DEFECTIVE VALVE. SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT RETURNED THE FOLLOWING DAY WITH SIGNIFICANTLY ELEVATED INTRAOCULAR PRESSURE DUE TO IMPROPER VALVE FUNCTION. THE DEVICE WAS SUBSEQUENTLY REMOVED AND REPLACED WITH ANOTHER IMPLANT.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 25414716 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  EXPLANT OF FP7 DUE TO SUSPECTED "OVER FILTERING." WOULD LIKE TO HAVE IT CHECKED TO SEE IF THE TUBE IS DEFECTIVE.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 25414696 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  PER THE SURGEON THE VALVE MALFUNCTIONED AND REMAINED OPEN. THE SURGEON REPLIED, "IT FAILED TO OPEN HIGH PRESSURES".

  Patient problems: Intraocular Pressure Decreased; Intraocular Pressure Increased

  MAUDE report 25194772 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  DEFECTIVE VALVE MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194752 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  TUBE COMING IN AND OUT OF EYE AND CAUSING IRITIS. NOT VISIBLE ON EXAM. DR. (B)(6).

  Patient problems: Iritis

  MAUDE report 24722879 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  AN ADVERSE EVENT WAS RECEIVED ON MARCH 16, 2026, FROM (B)(6) HOSPITAL, (B)(6), FOLLOWING SURGERY INVOLVING AN AHMED FP7 VALVE, BATCH: G1225, SN: (B)(6). (B)(6)., FEMALE. ON (B)(6) 2026, SHE UNDERWENT SURGERY, WHICH PROCEEDED WITHOUT COMPLICATIONS. APPROXIMATELY ONE WEEK POSTOPERATIVELY, CLINICAL HYPOTONY WAS OBSERVED.

  Patient problems: Choroidal detachment; Intraocular Pressure Decreased

  MAUDE report 24722858 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  LOCAL CASE NO. (B)(4) AN ADVERSE EVENT WAS RECEIVED ON MARCH 16, 2026, FROM (B)(6) HOSPITAL, (B)(6), FOLLOWING SURGERY INVOLVING AN AHMED FP7 VALVE, BATCH G1225, SN (B)(6): (B)(6)., FEMALE, (B)(6) YEARS OLD. ON (B)(6) 2026, SHE UNDERWENT SURGERY, WHICH PROCEEDED WITHOUT COMPLICATIONS. APPROXIMATELY ONE WEEK POSTOPERATIVELY, CLINICAL HYPOTONY AND CHOROIDAL DETACHMENT WERE OBSERVED, REQUIRING AN ADDITIONAL SURGICAL PROCEDURE. SHE UNDERWENT A SECOND SURGERY ON (B)(6) 2026. THIS CASE WILL BE REPORTED TO THE MOH.

  Patient problems: Choroidal detachment; Intraocular Pressure Decreased

  MAUDE report 24722848 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NEW GLAUCOMA SURGERY IS PLANNED FOR THE LEFT EYE (NEW AHMED VALVE IN THE SUPERIOR NASAL SECTOR). GIVEN THE LACK OF FILTRATION FROM THE PREVIOUS VALVE IN THAT EYE (ABSENCE OF THE VALVULAR AMPULLA, FREE INTERNAL OSTIUM OF THE TUBE, AND INCREASED INTRAOCULAR PRESSURE), AND CONSIDERING THE POSSIBILITY OF FAILURE IN THE VALVE'S DRAINAGE MECHANISM, THIS SURGERY IS BEING CONSIDERED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 23890258 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON FIRST SURGERY ON (B)(6), WHEN PRIMING, THE DOCTOR FELT IT WAS NOT SMOOTH BUT IMPLANTED ANYWAY. FOLLOWED THE PATIENT FOR A FEW DAYS, THE IOP DID NOT GET LOWER, AND EXCHANGED THE VALVE WITH NEW ONE IN EMERGENCY SURGERY ON (B)(6). [PATIENT INFORMATION: (B)(6) YEARS OLD, MALE, ASIAN, ASTHMA, HIGH BLOOD PRESSURE, IRREGULAR PULSE, USED MEDICINES: LEVOFLOXACIN, BETAMETHASONE, BROMFENAC, GLAUALPHA (DIAMOX), (QUENMET)].

  Patient problems: Intraocular Pressure Increased

  MAUDE report 23662960 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) - TUBE WASN'T FLOWING PROPERLY AFTER IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23588084 ↗
• MalfunctionNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUMMARY OF THE EVENT: BASED ON THE INVESTIGATION CONDUCTED, THE ANALYSIS OF THE DESCRIPTION, AND DURING THE USE OF THE MEDICAL DEVICE, IT WAS DETECTED THAT THE VALVE TUBE WAS PERFORATED WITH AN IRREGULAR TEAR. THE OPHTHALMOLOGIST SPECIALIZING IN GLAUCOMATOLOGY DECIDED TO REPLACE THE VALVE PLATE, WHICH SHE DID WITHOUT AFFECTING THE PATIENT. ANALYSIS OF THE PROBABLE CAUSE: THE PROBABLE CAUSE OF THE INCIDENT IS THE RUPTURE OF THE SILICONE MATERIAL OF THE VALVE TUBE, SUGGESTING A PROBLEM WITH THE MEDICAL DEVICE ITSELF. THIS COULD BE DUE TO A DEFECT IN THE DESIGN OR MANUFACTURE OF THE DEVICE. CLASSIFICATION OF THE EVENT: BECAUSE THE PROBLEM APPEARS TO BE RELATED TO THE DESIGN OR MANUFACTURE OF THE MEDICAL DEVICE, THIS EVENT IS CLASSIFIED AS AN ADVERSE INCIDENT. HOWEVER, AS THERE WAS NO IMPACT ON THE PATIENT OR SERIOUS COMPROMISE TO THEIR HEALTH, THE INCIDENT IS DETERMINED TO BE NON-SERIOUS. DETERMINATION OF THE SEVERITY OF THE EVENT: THE EVENT IS CLASSIFIED AS NON-SERIOUS BECAUSE, ALTHOUGH THERE WAS A PROBLEM WITH THE MEDICAL DEVICE, THERE WAS NO HARM OR INJURY TO THE PATIENT, AND THE MEDICAL INTERVENTION WAS EFFECTIVE WITH NO NEGATIVE SHORT- OR LONG-TERM CONSEQUENCES FOR THE PATIENT. C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475938 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS A LITTLE BIT OF STRANGE FEELING WHEN PRIMING THE AGV FP-7, BUT WE CARRIED OUT THIS OPERATION. PRE-OP IOP 22MMHG WENT UP TO 26MMHG POST-OP, AND RE-OPERATION IS PLANNED. DATE OF RE-OPERATION NOT KNOWN. WE WILL NOTIFY YOU AGAIN AFTER WE RECEIVED THE EXPLANTED VALVE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 23475855 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AHMED VALVE WAS INSERTED BUT SEVERE HYPOTONY NOTED WHICH COULD NOT BE STABILISED. VALVE NEEDED TO BE REMOVED AND REPLACED WITH A NEW AHMED VALVE. THE SECOND VALVE APPEARS TO BE DRAINING AS EXPECTED IMMEDIATELY POST OPERATIVE BUT THE PATIENT WILL BE FOLLOWED UP TOMORROW. DUE TO EXTENSIVE LENGTH OF SURGERY PATIENT NEEDED AN UNPLANNED OVERNIGHT STAY .

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 23393150 ↗
• MalfunctionOct 15, 2025Defective Device; Defective Device

  THESE ITEMS WERE REPORTED TO BE DEFECTIVE BY THE SURGEON. WHEN IRRIGATING BOTH SHUNTS, THE FLUID CAME FROM THE TOP OF THE CHANNEL. PT CODE: 4582. DEVICE CODES: 2588, 1354. REF REPORTS: MW5174471, MW5174472, MW5174473.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292426 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POTENTIAL DEVICE MALFUNCTION; VISION WORSENING, CHAMBER FLATTENING.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 23089346 ↗
• MalfunctionAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AHMED GLAUCOMA VALVE WITH SERIAL NUMBER [REDACTED] WAS MALFUNCTIONING AND THE DOCTOR DID NOT IMPLANT.

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

  MAUDE report 22896305 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER IMPLANTING AN FP7 VALVE OF LOT D0625, THE PATIENT WAS ADMITTED WITH ATALAMIA.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 22549459 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOT SATISFYING RESULT IN IOL REDUCTION.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 22549458 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT AHMED IMPLANT SURGERY ON (B)(6) 2025 BY PROF (B)(6). DURING THE SURGERY, PROF (B)(6) PRIMED THE TUBE, AND DID NOT NOTE OF ANY ABNORMALITIES. SURGERY WAS UNEVENTFUL. HOWEVER, PATIENT HAD PERSISTENT HYPOTONY POSTOPERATIVELY. SUBSEQUENTLY, A REPEAT SURGERY (TUBE REVISION) WAS DONE ON (B)(6) 2025 BY DR (B)(6) AND BELOW WERE THE SURGEON FINDINGS: -VALVE FAILURE -PERITUBULAR LEAK & OVER FILTRATION. THE TUBE WAS SUBSEQUENTLY LIGATED WITH 6/0 VICRYL SUTURE.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 22549457 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER IMPLANTING AN FP7 VALVE OF LOT D0625, THE PATIENT WAS ADMITTED WITH ATALAMIA.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 22549456 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT WAS OPERATED ON (B)(6) 2024. THE PROCEDURE ITSELF DID NOT PRESENT ANY COMPLICATIONS, THE VALVE PURGED WITHOUT PROBLEMS AND EVERYTHING WENT VERY WELL. THE NEXT DAY THE EYE PRESSURE WAS STILL AT 50 SO I WAITED A FEW DAYS TO REINTERVENE. IN A SECOND TIME I PROCEEDED TO SURGERY TO RE-PURGE THE DEVICE, A PROCEDURE THAT WAS CARRIED OUT SUCCESSFULLY. HOWEVER, THE NEXT DAY THE PRESSURE WENT THROUGH THE ROOF AGAIN. FINALLY IT WAS DECIDED TO EXPLANT THE DEVICE DUE TO THE HIGH PRESSURES AND THE DEVICE WAS REPLACED WITH IMMEDIATE GOOD RESULTS, WHICH CONFIRMED THAT THE DEVICE WAS NOT WORKING PROPERLY.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 22398576 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT MALFUNCTION AFTER IMPLANTED TO PATIENT. HAD TO BE EXPLANTED A WEEK LATER AND REPLACE WITH NEW ONE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 22179168 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FP7 IMPLANTED (B)(6) 2025, 1 WEEK AND 4 WEEK POST OP SHOWED NO REDUCTION IN IOP. FP7 EXPLANTED (B)(6) 2025 AND REPLACED WITH ANOTHER FP7. NEW FP7 PERFORMED AS EXPECTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 22136966 ↗