Guidance

Device-specific vigilance guidance: intraocular lenses

Updated 15 January 2025

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This publication is available at https://www.gov.uk/government/publications/reporting-adverse-incidents-intraocular-lenses/device-specific-vigilance-guidance-intraocular-lenses

Introduction  

This document provides guidance for manufacturers of devices for intraocular lenses. It outlines specific scenarios to consider when determining if an incident is reportable.  

You should read this document in conjunction with guidance on post market surveillance. 

The aim of this guidance is to complement the requirements of SI 2024 No. 1368 . You should read it in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements. 

What to report 

The following examples indicate how to report device performance problems that caused or contributed to an incident. The examples are for illustrative purposes only and do not constitute an exhaustive list. If in an incident appears to meet criteria contained in more than one category, ensure it is included in submissions under each reporting format, even if this results in duplication of reporting for that incident. 

1. Report as individual incidents (in line with statutory timescales) 

Clinical / symptomatic  

  • lens opacification 

  • lens explantation due to: 

  • decrease in best corrected visual acuity 

  • significant halos/glare/starbursts 

  • significant induced irregular astigmatism 

  • diplopia, or other significant visual disturbance 

  • lens discoloration 

  • lens defect 

  • endophthalmitis 

  • early cataract formation subsequent to phakic IOL implantation 

  • intraocular haemorrhage 

  • unexplained poor visual outcome as determined by the clinician 

  • posterior capsular opacification 

  • posterior capsular tear  

Device 

  • fracture of detachment of the haptic  

  • incorrect labelling or lens, including lens power  

  • failure of lens injectors 

2. Incidents that may be included in periodic summary reports (PSR) on agreement 

If you cannot use PSR, then report these events individually. 

Clinical / symptomatic    

  • IOL induced iritis   

  • post operative secondary glaucoma     

Device 

  • use errors resulting in serious injury and not falling into any identified category
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