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Model Number 590106AN |
Device Problem
Decrease in Suction (1146)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The patient interface (pi) suction ring may lose suction during a procedure.Label copy states corneal fixation vacuum loss can occur.There are several factors that may contribute to suction issues such as doctor¿s technique in applying the suction ring to the cornea, doctor¿s technique in squeezing the pi clip to secure the suction ring to the pi cone and patient anatomy affecting the interface between the patient¿s cornea and the suction ring.If there is any further relevant information, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported by the customer that their patient interface had suction loss during laser firing.There was no patient injury.The procedure was completed successfully.
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Manufacturer Narrative
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Additional information: section d9: device available for evaluation: yes.Date returned to manufacturer: 7 jan, 2021.Section h3: device returned to manufacturer: yes.Section h6: type of investigation - codes 10, 3331, 4110 and 4109.Section h6: investigation findings ¿ code 213.Section h6: investigation conclusion - code 67.Device evaluation: visual inspection was performed, and no obvious damage/defect was observed.Suction test was performed, and all results were found within specifications.The reported event cannot be confirmed.A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, lot history, and trending were 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.The review of the device history record (dhr) for the patient interface showed that there were no issues or non-conformities.The device 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.Conclusion: based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Correction: g3: date received by manufacturer: in initial report the date received by manufacturer indicated 12/8/21, however, the correct date is 12/7/2021.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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