The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the lens came out incorrectly went through into the vitreous body and tore the capsule.The information received states that "doctor had to catch it and hem it.The operation ended successfully.There are no complaints about the quality of vision".No product was available for return to rayner.The rayner risk analysis identifies the following as possible causes of "explosive expulsion of lens"; plunger advanced too quickly and forcing jammed plunger during iol insertion.Our review of production records for the rayone toric rao610t batch 119145470 showed that all manufacturing and quality checks were conducted with successful results.All devices released for distribution from this batch were within tolerance, met specification criteria and were without defects.A review of existing vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received against the rayone toric rao610t batch 119145470.
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