Age at time of event: unknown date of birth: unknown patient weight: unknown ethnicity and race: unknown a request for patient demographics and patient outcome was requested.However, no additional information was received.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|
Section h2: correction/additional information/device evaluation.Section d9: device available for evaluation "yes".Section h4: device manufacturing date was noted as mar 26, 2018 in the initial report.The correct manufacturing date is may 10, 2018.Device evaluation: a review of the device history record (dhr) showed that 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 and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|