ABSTRACT

The intraocular lens (IOL) industry was predicted to be worth USD 4.5 billion globally; in India, it is anticipated to increase by roughly $1 billion during the following five years. According to the 2017 medical devices rules, IOL is primarily categorised as Class C (moderate high risk), which means that IOL has a higher risk of adverse events. It is therefore crucial to report any anticipated or suspected adverse events to the national regulatory body in order to comply with regulation requirements. TASS, post-operative endopthalmitis, and severe ocular inflammations have all been associated to materials like polypropylene, acrylic, silicon hydrophobic/hydrophobic acrylic, and hydrogels used in IOL, according to a recent case study presented by IPC. . They also provided CDSCO with information suggesting that the product may have quality problems. They are currently reviewing these reports and taking appropriate action against the marketing authorization holder. It is better to report any adverse event at the initial level since a lack of knowledge about adverse reporting can result in a significant adverse event or death-injury. As a result, a workable solution has been recommended in this article in accordance with contemporary MvPI standards. Digital platforms will significantly revolutionise how stakeholders report adverse events related to medical devices. Keywords: Materiovigilance, MvPI, MDMC, IOL, TASS, Adverse event reporting
Publication date: 01/11/2024

https://ijbpas.com/pdf/2024/November/MS_IJBPAS_2024_8333.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.11.8333