Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section b3 - date of event: date unknown, as information was requested but not provided.Section e1 - telephone number: (b)(6).Section h3 - other (81): the system was not evaluated by a field service engineer.Therefore, a failure analysis of the complaint device has not been completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.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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Correction: through follow up it was learned that there were no events of edema related to the system.No further information was provided.Section h6 health effect: from 1791 to 4582, section h6 medical device problem code: from 2993 to 3189.Additional information: jjsv reviewed the information and determined that it does not meet the criteria for reportability therefore, no longer reportable.Please note that the information reported in sections d2 (common device name) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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