Acrysof Cachet Phakic Lens - Revised Usage Directions

Starting date:

August 8, 2012

Posting date:

September 3, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-23843

• Reason
• Affected products

Recalled Products

A. Acrysof Cachet Phakic Lens

Reason

The directions for use will be revised to include the following information:

• clarification that the Acrysof Cachet Phakic Lens is indicated for use for the correction of myopia between -6.0 d and -16.5 d.
• additional information regarding the risk of early acute Endothelial Cell Loss (ECL) to strengthen communication of benefits and risks of implantation to the patient.
• clarification on the frequency of monitoring for ECL by specular microscopy. The new recommendation is applicable for post-operative follow-up at one month, three months, and six months, and then at six-month intervals in collaboration with the treating physician.
• data on patients who experienced a greater than 30% endothelial cell loss (when compared to the preoperative cell count) and/or count below 1500 cells/mm² in the clinical studies.

Affected products