Catalog Number 8065751763 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/05/2018 |
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.(b)(4).
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Event Description
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An ophthalmic surgeon reported that during a procedure the footpedal did not work.The handpiece passed prime/tune and was aspirating but there was no phacoemulsification power.The procedure was completed.Additional information has been requested but not received.
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Manufacturer Narrative
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Additional information has been provided.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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