Model Number TABLETOP |
Device Problem
Increase in Pressure (1491)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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A customer reported that an ophthalmic console exhibited with excessive pressure.Additional information has been requested, but none received to date.
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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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Manufacturer Narrative
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Corrected information is provided in sections b.2,b.,5.H.2., and h.11.Based on this information received following submission of the initial report, this event excess pressure does not meet criteria for reporting as a malfunction.No further report will be submitted under this mfg: 2028159-2022-00598 the manufacturer internal reference number is: (b)(4).
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Event Description
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The initial decision to report was incorrect resulting in the initial report being submitted in error.This event (excess pressure) is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.
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Search Alerts/Recalls
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