CyPass Micro-Stent Model 241 (2018-08-30)

Starting date:

August 30, 2018

Posting date:

September 7, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67706

• 
  Reason
• 
  Affected products

Affected products

CyPass Micro-Stent. Model 241

Reason

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.

Affected products