Home / Recalls / Alcon Research, LTD. / Z-0186-2019

Z-0186-2019 Class I Terminated

Recalled by Alcon Research, LTD. — Sinking Spring, PA

Recall Details

Product Type
Devices
Report Date
October 31, 2018
Initiation Date
August 28, 2018
Termination Date
December 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14264 units

Product Description

CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. 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.

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.

Code Information

GTIN: 00380657540013, 0080657540013, 20380657540017, 10380657540010, 00380657540013 All lot/serial numbers

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