MHRA safety alert – EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs): stop using immediately and quarantine all preloaded EyeCee One lenses (26 January 2023)

Summary

The MHRA is aware of cases of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs), which are manufactured by NIDEK and distributed by Bausch + Lomb.

The root cause has not been identified and further investigations are ongoing with the manufacturer. 

Due to the potential risks for patient safety, you should stop using these IOLs and quarantine remaining stock immediately pending the results of further investigations. Additional communications will be issued shortly advising clinicians and affected patients on the next steps.

Content

Actions for ophthalmology, ophthalmic theatres, and Medical Devices Safety Officers. To be completed 26 January 2023

Please take the following actions immediately:

• Nominate a lead person to take responsibility for completing these actions. Note – we recommend including colleagues in purchasing, supplies, and the Medical Device Safety Officer (MDSO).
• Identify if your organisation uses these IOLs
• Stop using these impacted products immediately
• Quarantine these impacted IOLs until further notice.
• Consider using a suitable alternative product if available following local risk assessment
• Immediately notify any other departments who need to be aware of this notice.