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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

All IMPLANT, EYE VALVE devices →

Sources and updates

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