(b)(6).The system was evaluated by a field service engineer (fse).The field service found no issues with the unit.A field service checklist was performed.The unit complied with all factory settings.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.
|
It was reported a capsule tear occurred while the surgeon was performing epi nucleus and, due to the sudden stop of the system, a posterior capsular rupture (pcr) occurred.The system was restarted, and the surgeon proceeded with the surgery.The pcr enlarged and the surgeon decided to switch from a multifocal iol to a sensar 3-piece lens.The patient was aphakic at the end of the surgery for 1 hour 30 minutes.An unplanned vitrectomy was performed.The patient's outcome is unknown.
|