ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065752914 |
Device Problem
Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2020 |
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 that during cataract surgery, a surge in the fluid occurs resulting in the instability of the anterior chamber.This has occurred during several surgeries.The case have been completed without patient harm.
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Manufacturer Narrative
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The phacoemulsification handpiece was not returned for evaluation.The phacoemulsification handpiece manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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