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Model Number NGP680301 |
Device Problem
Reflux within Device (1522)
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Patient Problems
Eye Burn (2523); Zonular Dehiscence (2698)
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Event Type
Injury
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Manufacturer Narrative
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Date of event: date unknown/ not provided.Telephone number: (b)(6).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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Event Description
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A glaucoma specialist reported that is unsatisfied with our machine at present.The specialist reported the following, general issues and decided to for now suspend use of this machine and use the second machine they have on site: many burns at the incision.Chamber instability.Unexpected reflux.No specific details were provided and no interventions reported.No additional information was provided.
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Manufacturer Narrative
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Device evaluation: the whitestar signature pro was not made available for evaluation.Therefore, a failure analysis of the complaint device could not be performed.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 whitestar signature pro system 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.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
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Search Alerts/Recalls
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