Voluntary recall of selected lots of AMO Healon OVDs due to the remote possible presence of microscopic glass particles
Healthcare professional
Medical devices
3 May 2017
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AMO Singapore Pte Ltd would like to inform healthcare professionals of the voluntary recall of AMO Healon Ophthalmic Viscosurgical Devices (OVD) as there is a remote possibility that certain Healon OVD solutions in the affected lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. Healthcare professionals are advised to closely monitor patients who have received the affected Healon OVD for any complaints of persistent ocular symptoms or physical findings following surgery and arrange for a thorough examination. Healthcare professionals should also advise patients to seek medical help if they develop postoperative signs and/or symptoms such as pain or visual loss and to return all unused affected devices to AMO Singapore Pte Ltd. 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.
