Safety Alert – Allergan’s Xen 45 glaucoma surgical drainage device
22 October 2019
Allergan has contacted the RCOphth to provide a follow up regarding the hold on XEN 45. Allergan has reached out to regulatory agencies, and is working to initiate a voluntary recall of affected lots of XEN 45.
- During an inspection process a small number of units in an unreleased XEN 45 lot were observed to have trace amounts of polishing compounds that are used in the needle sleeve manufacturing process.
- As a precautionary measure Allergan issued a product hold of XEN 45 while investigating these findings. Allergan is committed to patient safety, and anticipates the voluntary recall will begin in the coming days and additional detailed information will be provided.
- Allergan will provide further details in the coming weeks on resupplying the market with newly manufactured lots of XEN 45.
- Please continue your routine post-operative follow up and report any adverse events to Allergan Product Surveillance. Allergan appreciates your understanding for the inconvenience this has caused you and your patients.
Contact details: Dr Sunni Patel (email@example.com) and Dr Jan Frolik (Jan.Frolik@allergan.com)