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Home » Devicemakers Must Trend Adverse Events for Implantable Lenses
Devicemakers Must Trend Adverse Events for Implantable Lenses
February 5, 2009
Intraocular lens (IOL) manufacturers should clearly note any foreseeable adverse events in the product labeling and subject such events to trend analysis as part of their postmarket surveillance system, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) says in a new guidance on vigilance for CE-Marked IOLs.