Allergan changes IOL manufacturing process to address lens yellowing problem.
This article was originally published in The Gray Sheet
Executive SummaryALLERGAN IOL MANUFACTURING CHANGES MADE TO PREVENT LENS YELLOWING, a problem that led to a voluntary recall of the devices. AMO PhacoFlex II Model SI-30NB intraocular lenses, manufactured between July 13, 1995 and Oct. 31, 1995, "have a somewhat yellow appearance" that was caused by the packaging material used to ensure sterility during that time period, the firm explains in a Feb. 5 voluntary recall notice. An investigation by the firm "led to manufacturing changes to prevent this phenomenon from recurring," the firm states.
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