Additional information provided in g.1., g.2., h.6., and h.10.A sample was not received at the manufacturing site for evaluation for the report of tip has been broken during surgery; therefore, the condition of the product could not be verified.A review of the device history records traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was released to the product¿s acceptable criteria, the root cause for customer complaint issue cannot be determined.The exact root cause for this complaint is unknown; therefore, specific action with regards to this complaint cannot be taken.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.The manufacturer internal reference number is: (b)(4).
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