Product Wiki · Recalls · Health Canada — Medical Devices

CyPass Micro-Stent Model 241 (2018-08-30) — recall 58370

Health Canada — Medical Devices · Canada · 2018-09-07 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
58370
Date of alert
2018-09-07
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Alcon is conducting a Voluntary Field Safety Corrective Action (withdrawal) of all versions of the CyPass Micro-Stent. The COMPASS-XT study was designed to collect safety data on the subjects who participated in the COMPASS study for an additional three years, with analysis of the completed data set at five years post-surgery. At five years, the CyPass Micro-Stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cypass-micro-stent-model-241-2

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