| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00300-1 |
| Product Name/Description |
AcrySof CACHET Phakic Lens (Used for the reduction or elimination of myopia)
ARTG: 159641 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
This action is an update to the previous ‘Urgent Recall for Product Correction' and 'Hazard Alert' letters issued by Alcon in February 2012 and July 2012 for the AcrySof CACHET Phakic Lens that described updates to the Directions for Use (DFU) and advised healthcare professionals of an acute adverse event for endothelial cell loss (ECL). Recently Alcon conducted a further data analyses of the five-year global study looking at the safety and efficacy of the AcrySof CACHET Phakic lens. Whilst the study data showed high efficacy as defined by visual acuity, approximately 1% of implanted lenses showed a risk for accelerated corneal endothelial cell loss (ECL) that led to explantation of the lens. The cause of ECL in individual patients is not well understood and is likely multi-factorial. However, analyses have indicated a trend for higher rates of ECL in:
- Patients with smaller eyes (those implanted with lens model L12500)
- Patients self-identified as being Asians. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Alcon is revising Directions for Use (DFU) with:
- updated clinical data to include results from 5 year clinical studies
- strengthen language to require (endothelial cell density (ECD) assessment of every 6 months
- provide guidelines for endothelial cell monitoring
For patients with the AcrySof CACHET Phakic Lenses already implanted, Alcon is recommending surgeons to remind the patients of the risks associated with undetected ECL and also, discuss the need for strict compliance with the monitoring requirements endothelial cell density ie, monitoring every six months) per the current version of the Directions for Use (DFU). Strict adherence to these requirements by patients will help to timely identify ECL and determine the appropriate treatment plan. |
| Contact Information |
02 9452 9273 - Alcon Regulatory Affairs |