Catalog Number 8065990714 |
Device Problem
Suction Problem (2170)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/27/2019 |
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 customer reported loss of suction during a lasik procedure.Additional information has been requested.
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Manufacturer Narrative
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The device history records (dhr) for the product lot was reviewed.No abnormalities that could have contributed to this event were found.The associated lot was released based on company's acceptance criteria.The root cause cannot be identified conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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