Acrysof Cachet Phakic Lens (April 02, 2013)

Starting date:

April 02, 2013

Posting date:

April 02, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-28447

• Reason
• Affected products

Reason

This notice is being provided to update the healthcare professionals on the actions alcon is taking concerning the alcon acrysof cachet phakic lens. This is further update to the communications alcon issued in February 2012 and July 2012, where they described updates to the directions for use (DFU) and advised healthcare professionals of an acute adverse event for endothelial cell loss (ECL). Alcon is developing a plan of action to ensure that physicians have the information they need to appropriately treat and monitor patients, and that patients can make an informed choice about their treatment. While this is taking place and until further guidance is issued, Alcon is voluntarily suspending shipment of the acrysof cachet phakic lens from their facilities. The study data showed high efficacy as defined by visual acuity, but a small subset of patients (approximately 1 percent of implanted lenses to date) showed a risk for accelerated corneal endothelial cell loss (ECL) that led to explantation of the lens. The company is currently discussing a plan of action with the health authorities.

Affected products