Ahmed™ ClearPath 250Recalls & reported problems
New World Medical, Incorporated · Glaucoma shunt · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00892064002348), received between Apr 13, 2020 and Sep 25, 2026 — classified as 6 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- No Apparent Adverse Event1
Patient problems
- Intraocular Pressure Decreased2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Eye Infections1
- Intraocular Pressure Increased1
- Intraocular Pressure, Delayed, Uncontrolled1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
After implantation, clear tube detached from shunt. Shunt was removed and secondary device was implanted without issue.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50899308 ↗InjuryJun 30, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE PATIENT HAD AN EYE INFECTION, THAT DID NOT START WITH THE TUBE BUT SPREAD TO THE TUBE RESULTING IN THE TUBE NEEDING TO BE REMOVED.
Patient problems: Eye Infections
MAUDE report 22367185 ↗InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LIGATION AND FENESTRATIONS WERE PERFORMED ON DEVICE. POST-OPERATION DAY 1 PATIENT PRESENTED WITH A 40 IOP AND WAS PRESCRIBED DIAMOX AND COMBIGAN. POST-DAY 6 PATIENT WAS "DOING OKAY" PER DOCTOR.
Patient problems: Intraocular Pressure Increased
MAUDE report 17941329 ↗InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT'S IOP DROPPED FROM 15 MMHG (BASELINE) TO 2 MMHG D1 POSTOP. IOP INCREASED TO 10 MMHG AT W1 POSTOP.
Patient problems: Intraocular Pressure Decreased
MAUDE report 17065177 ↗InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HOSPITAL REPORTED, "POST-OP HYPOTONY. SURGEON DETERMINED TOO MANY FENESTRATIONS WERE CREATED WHICH CREATED HYPOTONY"
Patient problems: Intraocular Pressure Decreased
MAUDE report 16329206 ↗InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PLACEMENT OF AHMED 250 (B)(4) ON (B)(6) 2019 WITH 7-0 VICRYL LIGATURE AND FENESTRATIONS. PT HAD A SMALL AVASCULAR LEAKING BLEB THAT HAD TO BE CLOSED. IOP 9-10 POST-OP. ON (B)(6) 2020: 2 MONTHS AFTER IMPLANTATION IOP 2 HYPOTONY PERSISTED WITH DEVELOPMENT OF CHOROIDALS. EXPLORATION IN OR (B)(6) 2020: THE ENTIRE CONJUNCTIVAL FLAP HAD NOT HEALED ONTO THE GLOBE. AQUEOUS WAS LEAKING UNDERNEATH CREATING THE HYPOTONY. THE AREA WAS EXTENSIVELY CAUTERIZED AND RESUTURED. ON (B)(6) 2020 AGAIN LEAKING ALONG THE SUTURE LINES, LARGE BANDAGE CTL WAS PLACED.
Patient problems: Intraocular Pressure, Delayed, Uncontrolled
MAUDE report 9955772 ↗
Other IMPLANT, EYE VALVE devices
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- 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™ Glaucoma Valve FP8New World Medical, Incorporated · IMPLANT, EYE VALVE4 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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