A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, service history, and trending was reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.The review of the device history record (dhr) for catalys-u laser system (s/n (b)(4)) showed that there were no issues or non-conformities.The system and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Based on the investigation results there is no indication of a product quality deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints.
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Correction: as part of an internal review of our mdrs it was identified that this case was a duplicate of catsweb folder 6608935.In that record the event description was more detailed and said that there was patient involvement but the surgery had not started.The account also stated that because of the shutter error prior to the treatment start the procedure was cancelled.Therefore, there was no malfunction of suction loss while laser firing.Based on this the event is no longer a reportable malfunction.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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