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U.S. Department of Health and Human Services

Class 1 Device Recall CyPass MicroStent

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  Class 1 Device Recall CyPass MicroStent see related information
Date Initiated by Firm August 28, 2018
Date Posted October 23, 2018
Recall Status1 Terminated 3 on December 18, 2020
Recall Number Z-0187-2019
Recall Event ID 80931
PMA Number P150037 
Product Classification Intraocular pressure lowering implant - Product Code OGO
Product CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
Code Information GTIN: 00380657540075, 10380657540072, 20380657540079  All lot/serial numbers
Recalling Firm/
Manufacturer		 Alcon Research, LTD.
714 Columbia Ave
Sinking Spring PA 19608-1405
For Additional Information Contact Customer Services
800-862-5266
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action The firm initiated their market withdrawal by letter on 08/28/2018. The firm requested surgeons immediately cease implantation of the device and return any unused product.
Quantity in Commerce 38682 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = OGO and Original Applicant = Alcon Research, Ltd
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