Field Safety Notice Alcon Phaco Tips Multiple Products (ICN 2220)

MHRA 5354195

Recall Reference: 30

Alert:

• The supplier Alcon has become aware of the potential for the Phaco Tip wrench to generate plastic shaving particles if the Phaco Tip is over-tightened to the handpiece to the point where the wrench slips over the tip-to-wrench interface.
• If particles are generated from the plastic wrench by overtightening the Phaco Tip and those particles subsequently enter the patient’s eye during surgery, there is a potential risk of intra- and/or post-operative complications, including intraocular tissue damage, bleeding, and/or associated inflammation.

Products Affected:

• These products are available from NHS Supply Chain via the eDirect route. Please see our Downloads ▼ section to refer to the product listing for further information on the affected product codes.

Next Steps:                      

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Follow the risk mitigation precautions provided in this notice when using identified catalogue numbers of Phaco Tips, procedure pack, or Alcon Custom Pak®.
• Complete the Response Form on page 5 of the Field Safety Notice and email to quality@alcon.com.
• Where potential alternatives are identified, customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.
• If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.