Product evaluation: the customer indicated the use of an approved cartridge and handpiece.The customer indicated the use of a viscoelastic, which is not qualified for the cartridge use.The product investigation could not identify a root cause.A voluntary recall of acrysof restor® and restor® toric iol models occurred on april 16, 2015, after an increased number of complaints of ocular inflammation post cataract surgery.Following the announcement of the recall, reports of post-surgical ocular inflammation for non recall lenses in (b)(4) were also received.It is not unusual to expect the number of complaints to increase following such an announcement as there is heightened awareness of the event.The increase in complaints observed for the non recall models is specific to the (b)(4) market.Based on the interpretation that this increase in the number of reports of post-surgical ocular inflammation for the non recall models is below the published rates (oshika t, et al.Incidence of endophthalmitis following cataract surgery in (b)(4).Acta ophthalmol.Scand 2007:85:848-851), we will continue to closely monitor for any potential trends or signals.
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