Alcon Research, LTD.: Medical Device Recall in 2018 - (Recall #: Z-0187-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: August 28, 2018

Date Posted: October 31, 2018

Recall Number: Z-0187-2019

Event ID: 80931

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.

Status: Terminated

Product Quantity: 38682 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated