Voluntary recall of all lots of Allergan XEN Glaucoma Treatment System due to detection of trace residual polishing compounds from manufacturing process

A Dear Healthcare Professional Letter has been issued by Allergan Singapore Pte Ltd to inform healthcare professionals of the recall for all unused lots of Allergan XEN Glaucoma Treatment System due to the detection of trace amounts of residual polishing compounds from the manufacturing process. Healthcare professionals are advised to cease using the affected devices as the foreign particles on the needle assembly may be transferred to the patient’s eye during procedure, possibly resulting in irritation, inflammation, local allergic reaction/ hypersensitivity, iritis/iridocyclitis or, uveitis/sterile endophthalmitis due to introduction of an intraocular foreign body. Removal of an implanted XEN device is not recommended. Healthcare professionals are advised to continue the post-operative follow up regime as per local standard of care for patients who have undergone XEN surgery. Please refer to the letter for 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.