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Health Sciences Authority
Dear Healthcare Professional Letters

Voluntary recall of CyPass® Micro-Stent following long-term safety study results on increased risk of endothelial cell loss

Audiences

Healthcare professional

Product type

Medical devices

10 September 2018

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Alcon Pte Ltd would like to inform healthcare professionals of a voluntary recall of all models of CyPass® Micro-Stent. An analysis of the dataset from COMPASS-XT long-term safety study showed that the CyPass® Micro-Stent group experienced statistically significant endothelial cell loss (ECL) at five years post-surgery compared to the group who underwent cataract surgery alone. Increased ECL was correlated with the CyPass® Micro-Stent position within the angle, with ECL increasing in relation to the number of retention rings noted on clinical examination with gonioscopy, particularly with two or more retention rings visible.  Healthcare professionals are advised to cease further implantation of all CyPass® Micro-Stent and return all unused devices. Patients implanted with CyPass® Micro-Stent should undergo: (i) post-operative gonioscopy (if not performed previously) to assess CyPass® Micro-Stent position; and (ii) periodic assessments of endothelial cell density using specular microscopy. Surgeons who are considering stent adjustment or removal should review the information in the CyPass® Micro-Stent instructions for use. After the immediate postoperative period, trimming of the proximal end of the CyPass®Micro-Stent may be considered when the anterior position of the stent appears likely to compromise corneal endothelial health.  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.

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