The sales suspension of the Alcon AcrySof® CACHET® Phakic Lens due to risks of accelerated corneal endothelial cell loss (ECL)
Healthcare professional
Medical devices
9 April 2013
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Alcon Pte Ltd is voluntarily suspending its sales of the Alcon AcrySof® CACHET® Phakic Lens due to risks of accelerated corneal endothelial cell loss (ECL). The 5-year clinical study on the safety and efficacy of the Alcon AcrySof® CACHET® Phakic Lens was recently completed and based on analysis of the data, Alcon had identified that a small subset of patients (approximately 1% of the patients implanted with the lenses to date) may be at risk for accelerated corneal endothelial cell loss, leading to explantation of the Alcon AcrySof® CACHET® Phakic Lens. Alcon has consulted the Medical Advisory Boards on the safety findings and will be developing a risk management plan, to ensure that physicians will have the necessary information required to appropriately treat and monitor their patients using these lenses, and to allow their patients to make informed decisions about their treatment plans. Please refer to the Dear Healthcare Professional Letter for more details.
Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.
Step 1: Select your profession under ‘For Healthcare Professionals’.
Step 2: Click on ‘Useful links’.
Step 3: Click on ‘MOH Alert’ and log in via Singpass.
Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.
