Information unknown/ not provided.Per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Telephone number: (b)(6).(b)(4).Device evaluation: as a result of this complaint, a field service engineer performed a check of the system.The vacuum values on surgeon mode 2 were checked and as per checklist and vacuum were within specifications.All values relating to the whitestar device were also within specifications, no adjustments or calibrations required.Manufacturing record evaluation: the manufacturing records for the whitestar signature pro system were reviewed.The product was manufactured and released according to specification.A review of the device history record, complaint trending, and risk documentation for this device was performed.There were no discrepancies or non-conformances experienced during manufacturing.The system and its components met all specifications prior to being released.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.The device functioned as intended.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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