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Originator:		National Patient Safety Alert - MHRA
Issue date:		01-Feb-2023 15:48:26
This alert has been issued to:
		Care Trusts Mental Health Trusts Specialists Trusts Learning Disabilities Trusts Mental Health & Social Care Trusts Ambulance Trusts Mental Health & Learning Disabilities Trusts Acute Trusts Community Trusts
		Other contacts Independent Healthcare Providers (registered with CAS) Clinical Commissioning Groups NHS Regional Offices Special Health Authorities Territorial CMOs in Northern Ireland, Scotland & Wales Regional Directors of Public Health Director of Public Health NHS 111 and Out of hours providers GP Practices Primary Care Networks GP Practices 1
Action category:		Action
Title:		NIDEK EyeCee preloaded and EyeCee One Crystal preloaded Intraocular Lenses (IOLs): risk of increased intraocular pressure
Broadcast content:		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 U.K. Ltd. Increased intraocular pressure can lead to optic nerve damage and vision loss if left untreated. A Device Safety Information notification (DSI/2023/001) was issued on 26 January 2023 stating that users should stop using these products immediately and quarantine all preloaded EyeCee One and EyeCee One Crystal IOLs, pending the results of further investigations. GP Practices: we are sending you this alert in case you receive any enquiries from patients who may recently have had cataract surgery.
Additional information:		NHS England Regions: this alert is relevant to optometry contractors - please arrange cascade.
Alert reference:		NatPSA/2023/003/MHRA
Action underway deadline:		03-Feb-2023
Action complete deadline:		16-Feb-2023
Attachments:		NatPSA_2023_003_MHRA.pdf