188体育

滨苍迟谤辞诲耻肠迟颈辞苍听听

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

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

The aim of this guidance is to complement the requirements of . You should read it in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements.听

What to report聽

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.听

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

Clinical / symptomatic聽聽

• lens opacification聽

• lens explantation due to:聽

• decrease in best corrected visual acuity聽

• significant halos/glare/starbursts聽

• significant induced irregular astigmatism聽

• diplopia, or other significant visual disturbance聽

• lens discoloration聽

• lens defect聽

• 别苍诲辞辫丑迟丑补濒尘颈迟颈蝉听

• early cataract formation subsequent to phakic IOL implantation聽

• intraocular haemorrhage聽

• unexplained poor visual outcome as determined by the clinician聽

• posterior capsular opacification聽

• posterior capsular tear聽聽

顿别惫颈肠别听

• fracture of detachment of the haptic聽聽

• incorrect labelling or lens, including lens power聽聽

• failure of lens injectors聽

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

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

Clinical / symptomatic聽聽聽聽

• IOL induced iritis聽聽聽

• post operative secondary glaucoma聽聽聽聽聽

顿别惫颈肠别听

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