The reference (b)(4) has been allocated to this case by rayner.The verbatim report received states "sudden burst of built-up pressure in the nozzle, iol shoot off abruptly into the bag.Nearly caused pc rupture".The product is not available for return.The device was discarded by the healthcare facility.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 020149691 showed that all manufacturing and quality checks were conducted with successful results.All devices released for distribution from these batches 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 020149691.
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On (b)(6) 2022, rayner received notification from its malaysia distributor of an event that occurred during use of a rayone toric rao610t.The verbatim report received states "sudden burst of built-up pressure in the nozzle, iol shoot off abruptly into the bag.Nearly caused pc rupture".
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