Urgent Voluntary Recall of Certain HOYA One-Piece Intraocular Lenses

HOYA Medical Singapore Pte Ltd is voluntarily recalling a limited number of HOYA-PS AF-1 Hoya Preloaded System Intraocular Lens (iSert® 250 and iSert® 251) due to the traces of residual foreign particulates on them. This contamination affects lenses manufactured in between October 2011 to January 2013 and there has been a higher than expected rate of inflammation and/or endophthalmitis being reported for lenses used between this period. According to product owner, global occurrence rate for inflammation and/or endophthalmitis is in the region of 0.08%. HOYA Medical Singapore Pte Ltd is working to rectify this contamination issue and HOYA Medical Singapore Pte Ltd encourages healthcare professionals to track the patients that have been implanted with the affected lenses within the last 6 months, to arrange for follow-up visits and report any incidents of inflammation and/or endophthalmitis to the physician. 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.