Ahmed™ Glaucoma Valve FP8Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00892064002126), received between Apr 25, 2019 and Sep 14, 2022 — classified as 4 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISTRIBUTOR REPORTED, "THIS VALVE WAS IMPLANTED ON (B)(6) 2022, BUT IT DID NOT REDUCE THE PATIENT'S IOP. THIS VALVE WAS THEN EXPLANTED AND REPLACED WITH ANOTHER FP-8. THE SURGEON ASSUMES THE CAUSE COULD BE MALFUNCTION OF THE VALVE."

  Patient problems: Intraocular Pressure Decreased; Intraocular Pressure Increased

  MAUDE report 15420388 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HIGH IOP AND NO LIGHT PERCEPTION.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 9862757 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) YEAR OLD WITH FP8 - POST-OP DAY 1; COMPLETE COLLAPSE OF AC.

  Patient problems: Intraocular Pressure, Delayed, Uncontrolled

  MAUDE report 8553127 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) YEAR OLD MONOCULAR PATIENT - PLACED AN FP8, LEFT VISCOELASTIC IN CHAMBER AND TREATED WITH ATROPINE. CHAMBER WAS MODERATELY SHALLOW WITH COMPROMISED VISION D1. DOCTOR ENDED UP INJECTING HER WITH VISCOELASTIC ON DAY 6 DUE TO CONTINUED SHALLOW AC. SHE IS MAKING SLOW VISUAL RECOVERY.

  Patient problems: Intraocular Pressure, Delayed, Uncontrolled

  MAUDE report 8553112 ↗