# P150037: CyPass Micro-Stent

- Pathway: PMA
- Applicant: Alcon Research, Ltd.
- Decided: Jul 29, 2016 after 282 days
- Product code: OGO (Intraocular Pressure Lowering Implant)
- Device class: 3
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Aug 28, 2018 · Class I · Z-0188-2019: 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 w
- Aug 28, 2018 · Class I · Z-0187-2019: 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 w
- Aug 28, 2018 · Class I · Z-0185-2019: 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 w
- Aug 28, 2018 · Class I · Z-0186-2019: 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 w

Source page: https://510kreport.com/device/P150037
Methodology: https://510kreport.com/methodology