Health product recall

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

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

CyPass Micro-Stent. Model 241

Lot or serial number

More than 100 numbers, contact manufacturer

Model or catalog number
  • 8065754010
  • CYP 241
Companies
Manufacturer
Alcon Laboratories Inc.
6201 South Fwy
Fort Worth
76134
Texas
UNITED STATES