Update on AMO AR40e Intraocular Lens (IOL) Field Safety Action

Abbott Medical Optics Inc. (AMO) is voluntarily recalling a limited number of AMO Sensar Opti-Edge Soft Acrylic Intraocular Lens (Model: AR40e) due to the incorrect labelling of the diopter power of two production lots of Sensar AR40e IOLs. This mislabelling event affects 78 units of 23.5 diopter IOLs and 77 units of 18.0 diopter IOLs globally. Fifteen mislabelled lenses were supplied to Singapore. AMO working to identify the root cause of the mislabelling event and its rectification. Pending HSA's review of the root cause analysis and corrective and preventive actions, further supply of AR40e has been put on hold. AMO encourages healthcare professionals to track the patients that have been implanted with the affected lenses, to arrange for follow-up visits and evaluate their final refractive outcome. 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.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

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

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