CyPass 8065754003Recalls & reported problems
Alcon Laboratories, Inc. · CyPass System · Class 3
All models of Cypass (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380657540037), received between Apr 10, 2020 and Apr 10, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Aug 28, 2018Terminated
Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.
Z-0185-2019 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Loss of Vision1
- Pain1
- Retinal Tear1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2020Improper or Incorrect Procedure or Method
DR (B)(6) CLINIC OF (B)(6) IMPLANTED ALCON CYPASS MICRO STENT IN MY LEFT EYE AFTER HE MISDIAGNOSED ME WITH GLAUCOMA; SUBSEQUENT ASSESSMENTS WITH 3 OTHER OPHTHALMOLOGIST SUBSTANTIATED MALPRACTICE. MEDICAL TESTS AND RESULTS: DR (B)(6). DR (B)(6). YOU HAVE MY PERMISSION TO REQUEST MEDICAL RECORDS. I NEED TO GET THIS IMPLANT REMOVED. IT IS CAUSING PAIN AND VISION LOSS AND RETINAL TEAR AS WELL AS ENDOTHELIAL CELL LOSS. I AM CONCERNED TO AVOID THE NEED FOR A CORNEA TRANSPLANT. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Loss of Vision; Pain; Retinal Tear
MAUDE report 9952894 ↗
Other Intraocular Pressure Lowering Implant devices
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- iStent inject W G2-WGlaukos Corporation · Intraocular Pressure Lowering Implant97 reports
- Cypass 8065754007Alcon Laboratories, Inc. · Intraocular pressure lowering implant1 recall0 reports
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- iStent GTS100RGlaukos Corporation · Intraocular Pressure Lowering Implant17 reports
- iStent inject W Trabecular Micro-Bypass System with Infinite Injector Technology iS2Glaukos Corporation · Intraocular Pressure Lowering Implant12 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 · each recall links to the FDA recall notice
- 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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