Cypass 8065754007Recalls & reported problems
Alcon Laboratories, Inc. · CYPASS ULTRA SYSTEM CYPASS MICRO-STENT CYPASS' APPLIER · Class 3
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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. How this data works · Data updated Oct 13, 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-0187-2019 · Root cause: Device Design · FDA record ↗
Other Intraocular pressure lowering implant devices
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- iStent inject W G2-WGlaukos Corporation · Intraocular Pressure Lowering Implant97 reports
- CyPass 8065754003Alcon Laboratories, Inc. · Intraocular Pressure Lowering Implant1 recall1 report
- iStent inject G2-M-ISGlaukos Corporation · Intraocular Pressure Lowering Implant33 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.