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Recall Observatory FDA recall evidence

Device product

CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.

Z-0187-2019

August 28, 2018

Class I

Product summary

Firm
Alcon Research, LTD.
Event
Event 80931
Status
Terminated
Classification
Class I
Quantity
38682 units
Official record key
device-enforcement:Z-0187-2019

Official wording

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.

Code information: GTIN: 00380657540075, 10380657540072, 20380657540079 All lot/serial numbers

Distribution pattern: Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Finland, Germany, Hong Kong, Iceland, Italy, Mexico, Peru, Singapore, Spain, Sweden, Switzerland, United Kingdom, and Uruguay.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.