Intraocular Pressure Lowering Implant
FDA adverse event reports and recall history for intraocular pressure lowering implant (product code OGO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,653
- Deaths
- 0
- Injuries
- 2,010
- Malfunctions
- 643
Reports per year
Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2018-10-23TerminatedDevice Design
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
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.
- 2018-10-23TerminatedDevice Design
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
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.
- 2018-10-23TerminatedDevice Design
CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
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.
- 2018-10-23TerminatedDevice Design
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
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.
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