A customer reported the cutter cracked and came off in the eye during a procedure with two packs.The surgeon removed the cracked ends from the eye(s).Procedure completed, patient impact information is not known.Additional information was requested; however, none has been received to date.This is one of two reports for this facility.
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No sample has been returned for evaluation.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination for device component lots traceable to the reported lot number indicates there are two additional complaints associated with the component lots for the reported issue.A sample was not returned and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown as no sample was returned; therefore, specific action with regards to this complaint cannot be taken.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.The manufacturer internal reference number is: (b)(4).
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