This guidance document gives advice to manufacturers on the notification of adverse incidents involving intra-ocular lenses under medical devices vigilance system. It includes, but is not limited to, the following types of intraocular lenses: posterior chamber; phakic; anterior chamber; multifocal; and accommodated. It is intended to facilitate uniform application implementation of the medical devices directive.
The kinds of things should be reported include:
- Any deterioration or malfunction of an intraocular lens or any inadequacy in instructions for use which has led, on might lead to, a serious deterioration in the state of health and vision.
- The intraocular lens has been subject to a field safety corrective action
- Common faults that require reporting are also listed
The guidance also goes on to give some details about Periodic Summary Reporting and Adverse Incident Trending, its a short guidance but should be look at and considered by those working in the area.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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