Catalog Number 8065751763 |
Device Problem
No Device Output (1435)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A health professional reported that an ophthalmic surgical console exhibited no phacoemulsification power.The issue was resolved after the system was rebooted.Procedure details and patient involvement information is unknown.There was no report of any patient harm.Additional information has been requested.
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Manufacturer Narrative
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The company service representative examined the system and was unable to confirm or replicate the reported event.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to user error.The manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate the manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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