The sales suspension of the Alcon AcrySof® CACHET® Phakic Lens due to risks of accelerated corneal endothelial cell loss (ECL)

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.
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.