Recall: CyPass Micro-Stent For Surgical Glaucoma
On 2018-08-29, the FDA announced that Alcon is conducting a recall on Micro-Stent For Surgical Glaucoma due to a possible undetermined hazard. The recalled products were sold under the brand name(s) CyPass during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 1 medical devices recalls due to potential undetermined hazard . Additionally, there have been 2 drug and medical device recalls due to other health hazards as well as 70 food recalls.
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Micro-Stent for Surgical Glaucoma
Brand Name(s): CyPass
Reason for Recall: Significant endothelial cell loss
Official Recall Date: 2018-08-29
Additional information provided by the FDA.gov:
Decision based on five-year data from COMPASS-XT long-term safety study Alcon advises ophthalmic surgeons to cease further implantation Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.