ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065750833 |
Device Problems
Use of Incorrect Control/Treatment Settings (1126); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 healthcare professional reported that during multiple procedures, the console did not automatically sense different types of phacoemulsification tips.It was also reported that the machine comes up with random settings, missing out the sculpt step and going to the quadrant removal step directly after pre phacoemulsification and the powers of the settings are incorrect.The procedures were completed.Additional information was requested.
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Search Alerts/Recalls
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