Recall Z-0187-2019— Alcon Research, LTD.
Class I · Terminated
Class I FDA medical device recall by Alcon Research, LTD., initiated 2018-08-28, terminated 2020-12-18. FDA's recall record names no specific 510(k) clearance for this event. Product: CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.. Reason: 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..
- Recalling firm
- Alcon Research, LTD.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-08-28
- Terminated
- 2020-12-18
- Firm location
- Sinking Spring, PA, United States
Product description
CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.