Ahmed Glaucoma ValveRecalls & reported problems across all models

We found 3 models of Ahmed Glaucoma Valve by New World Medical, Incorporated in the FDA's device registry (GUDID). Together they are named in 272 adverse event reports in the FDA's MAUDE database, received between May 3, 2016 and Sep 25, 2026 — classified as 209 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Device Issue” (21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Ahmed Glaucoma Valve problems

Ahmed Glaucoma Valve models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Ahmed™ Glaucoma Valve FP7

  IMPLANT, EYE VALVE
  266 reports
• Ahmed™ Glaucoma Valve FP8

  IMPLANT, EYE VALVE
  4 reports
• Ahmed™ Glaucoma Valve S2

  IMPLANT, EYE VALVE
  2 reports

Recent Ahmed Glaucoma Valve adverse event reports

The 15 most recent reports across all models, 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 ↗