Ahmed™ Glaucoma Valve S2Recalls & reported problems
New World Medical, Incorporated · Polypropylene Glaucoma Drainage Device · Class 2 · Implant
All models of Ahmed Glaucoma Valve (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00892064002133), received between Mar 23, 2017 and Mar 15, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Physical Property Issue” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Physical Property Issue2
- Device Issue1
- Torn Material1
Patient problems
- Intraocular Pressure, Delayed, Uncontrolled2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 15, 2018Device Issue; Physical Property Issue; Torn Material; Device Issue; Physical Property Issue; Torn Material
PATIENT HAS AN AGV IMPLANTED ON (B)(6) 2018. ON IMPLANTATION DR. THOUGHT THE VALVE LOOKED NORMAL AND WAS PATENT WHEN PRIMED. THE PROCEDURE WENT SMOOTHLY AND THERE WERE NO COMPLICATIONS. PATIENT RETURNED ON (B)(6) 2018 WITH A PAINFUL RED EYE WITH IOP OF 43MMHG IN HIS OPERATED EYE. THE ANTERIOR CHAMBER WAS FORMED WITH MODERATE CORNEAL EDEMA. THE VALVE WAS WELL SECURED UNDER THE CONJUNCTIVA.
Patient problems: Intraocular Pressure, Delayed, Uncontrolled
MAUDE report 7343675 ↗InjuryMar 23, 2017Physical Property Issue; Physical Property Issue
"VALVE WAS FAULTY AND OVER-DRAINED FROM DAY 1 - WE BROUGHT THE PATIENT BACK TO THE OPERATING ROOM (OR) AND TIED IT OFF."
Patient problems: Intraocular Pressure, Delayed, Uncontrolled
MAUDE report 6427777 ↗
Other IMPLANT, EYE VALVE devices
- XEN Glaucoma Treatment System 5513-001Allergan, Inc. · Implant, Eye Valve280 reports
- Ahmed™ Glaucoma Valve FP7New World Medical, Incorporated · IMPLANT, EYE VALVE266 reports
- iStent Infinite iS3Glaukos Corporation · Implant, Eye Valve38 reports
- BAERVELDT GLAUCOMA IMPLANT (350) BG101350Johnson & Johnson Surgical Vision, Inc. · IMPLANT, EYE VALVE35 reports
- iStent infinite iS3Glaukos Corporation · Implant, Eye Valve21 reports
- BAERVELDT GLAUCOMA IMPLANT (250) BG103250Johnson & Johnson Surgical Vision, Inc. · IMPLANT, EYE VALVE16 reports
- EX-PRESS® P-50Alcon Laboratories, Inc. · Implant, Eye Valve12 reports
- Ahmed™ ClearPath 250New World Medical, Incorporated · IMPLANT, EYE VALVE6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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