Catalog Number 8065990941 |
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 09/23/2019 |
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.(b)(4).
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Event Description
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A customer reported a loss of suction during lasik flap creation.Additional information requested.
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Manufacturer Narrative
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The root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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