| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01013-1 |
| Product Name/Description |
AcrySof CACHET PHAKIC Lens
ARTG Number: 159641 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Alcon are 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.
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. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
If you have inventory of the CACHET Phakic Lens, these lenses can be returned to Alcon for reimbursement. Patients with the CACHET Phakic Lenses already implanted, Alcon is recommending opthamologists adhere to the monitoring requirements described in the current DFU. Adherence to these requirements will help to timely identify significant ECL and determine the appropriate treatment plan. For more details, please see http://www.tga.gov.au/safety/alerts-device-acrysof-cachet-phakic-lens-140924.htm .
This action has been closed out on 22/10/2018 |
| Contact Information |
02 9452 9273 - Alcon Laboratories Australia |