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 09/07/2018 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported vacuum was lost during flap creation.The procedure was completed and there was no patient harm.
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Manufacturer Narrative
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The root cause could not be identified conclusively.The most possible root cause may be unnoticed movement of the patient during surgery, too much fluid on the eye or docking technique of the surgeon.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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