The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning AcrySof CACHET PHAKIC Lens manufactured by Alcon Laboratories Inc.
The manufacturer is discontinuing the sale of 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.
According to the manufacturer, the clinical data analysis indicates an increase in the number of cases of endothelial cell loss (ECL). In the clinical study, patients' endothelial cell density (ECD) levels are monitored at 6 month intervals, as recommended by the current CACHET Phakic Lens directions for use (DFU). To date, only 2.7% of the 1,323 CACHET Phakic Lenses implanted in the clinical study were explanted due to ECL.
For patients with the CACHET Phakic Lenses already implanted, the manufacturer recommends adherence to the monitoring requirements described in the current DFU. Adherence to these requirements by patients will help to timely identify significant ECL and determine the appropriate treatment plan.
For details, please refer to the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01013-1
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 September 2014