Acrysof Cachet Phakic Lens (2014-09-19)

Starting date:

September 19, 2014

Posting date:

October 2, 2014

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-41651

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  Reason
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  Affected products

Recalled Products

Acrysof Cachet Phakic Lens

Reason

Alcon is voluntarily discontinuing the Cachet Phakic Lens based on data analysis from an ongoing 10-year study to evaluate the safety of the Cachet Phakic Lens in patients with myopia (near-sightedness) from -6.0 to -16.5 D vision correction.  Patients with the Cachet Phakic Lens should continue with the ongoing monitoring and evaluation outlined in the current directions for use (DFU).  In cases where an explant is warranted in accordance with the criteria set out in the attached DFU, Alcon will work with the treating ophthalmologist to ensure that the affected patients receive an explant without incurring out-of-pocket costs.

Affected products